Infusion pump system and methods

ABSTRACT

Some embodiments an infusion pump system can be configured to modify alarm limit parameters as the user&#39;s insulin load increases or decreases. Moreover, in particular embodiments, the infusion pump system can be configured to provide a “missed bolus” or “missed meal” alarm in response to the user&#39;s blood glucose characteristics, the user&#39;s insulin load information, or the like.

CROSS-REFERENCE TO RELATED APPLICATION(S)

This application is a continuation of U.S. patent application Ser. No.12/251,629 filed on Oct. 15, 2008 (now U.S. Pat. No. 8,287,487), theentire contents of which are hereby incorporated by reference

TECHNICAL FIELD

This disclosure relates to portable infusion pump systems to deliverfluids, such as insulin infusion pump systems or the like.

BACKGROUND

Pump devices are commonly used to deliver one or more fluids to atargeted individual. For example, a medical infusion pump device may beused to deliver a medicine to a patient as part of a medical treatment.The medicine that is delivered by the infusion pump device can depend onthe condition of the patient and the desired treatment plan. Forexample, infusion pump devices have been used to deliver insulin to thevasculature of diabetes patients so as to regulate blood-glucose levels.In some circumstances, the dosage of medicine delivered by the infusionpump acts within the patient's body over a long period of time. Suchconditions, for example, may cause a patient to have an amount ofnon-activated insulin in his or her system even hours after the insulindosage was dispensed from the infusion pump device.

SUMMARY

Some embodiments an infusion pump system can provide an alarm (includingan alert, a safety alarm, or the like) in response to a detectedcondition that exceeds an alarm limit parameter. In some circumstances,the infusion pump system can determine the user's insulin load (e.g., anestimated amount of insulin already delivered to the user's body), andthereafter adjust the alarm limit parameter in response to the user'sinsulin load. Accordingly, the alarm limit parameters may dynamicallychange over time as the user's insulin load increases or decreases. Sucha feature can be valuable to a user when the infusion pump is operatedin conjunction with a glucose monitoring device. Moreover, the infusionpump system can be configured to provide a “missed bolus” or “missedmeal” alarm in response to the user's blood glucose characteristics, theuser's insulin load information, or the like.

In some embodiments, a medical infusion pump system may include aportable pump housing that receives insulin for dispensation to a user.The pump housing may at least partially contain a pump drive system todispense the insulin through a flow path to the user. The system mayalso include a controller that communicates with the pump drive systemto dispense the insulin from the portable pump housing, and a monitoringdevice that communicates glucose information to the controller. Theglucose information may be indicative of a blood glucose level of theuser. The controller may output an alarm when the glucose informationindicates that the blood glucose level reaches beyond a glucose alarmlimit parameter. The glucose alarm limit parameter may be adjustable bythe controller in response to an insulin load of the user.

Particular embodiments may include a method of operating an insulininfusion pump system. The method may include receiving glucoseinformation indicative of a glucose level of a user. The method may alsoinclude determining an insulin load of the user indicative of estimatedamount of insulin delivered to the user's body. The method may furtherinclude, in response to determining the insulin load of the user,modifying at least one of an upper alarm limit parameter and a loweralarm limit parameter. The method may also include outputting an alarmwhen the glucose information indicates that the glucose level is greaterthan the modified upper alarm limit parameter or is less than themodified lower alarm limit parameter.

In some embodiments, a medical infusion pump system may include aportable pump housing that receives insulin for dispensation to a user.The pump housing may at least partially contain a pump drive system todispense the insulin through a flow path to the user. The system mayalso include a controller that communicates with the pump drive systemto dispense the insulin from the portable pump housing, and a monitoringdevice that communicates glucose information to the controller. Theglucose information may be indicative of a blood glucose level of theuser, and the glucose information may be stored in a computer-readablememory device over a period of time. The controller may access theglucose information stored in the memory device to detect a glucoseinformation pattern indicative of a missed insulin bolus.

In further embodiments, a medical infusion pump system may include aportable pump housing that receives insulin for dispensation to a user.The pump housing may at least partially contain a pump drive system todispense the insulin through a flow path to the user. The system mayalso include a controller that communicates with the pump drive systemto dispense the insulin from the portable pump housing, and a monitoringdevice that communicates glucose information to the controller, theglucose information being indicative of a blood glucose level of theuser. The glucose information may be stored in a computer-readablememory device over a period of time. The controller may access theglucose information stored in the memory device to detect a glucoseinformation pattern indicative of missed food intake.

These and other embodiments described herein may provide one or more ofthe following advantages. First, some embodiments of the infusion pumpsystem may reduce the likelihood of nuisance alarms to the user byautomatically adjusting one or more of the alarm limit parameters inresponse to the user's current insulin load. For example, when aninsulin infusion pump is operated in conjunction with a continuousglucose monitoring device, the insulin pump controller can be configuredto provide an alarm in response to the user's blood glucose levelincreasing above a high glucose alarm limit (e.g., if the detectedglucose level exceeds a set parameter such as 200 mg/dL). However, ifthe user has a high insulin load (due to a large amount of insulinalready delivered to the user's body which has not yet acted), theuser's blood glucose level is likely to decrease substantially over timeas the non-activated insulin reaches the user's blood stream. In thesecircumstances, the insulin pump controller can be configured toautomatically increase the high glucose alarm limit (e.g., to 210 mg/dLin one example) in order to reduce the occurrence of nuisance alarms tothe user. Additional examples are described herein.

Second, some embodiments of the infusion pump controller can dynamicallychange a plurality of alarm limits over time as the user's insulin loadincreases or decreases. For example, the infusion pump controller can beconfigured to perform a number of operations to modify both the lowglucose alarm limit and the high glucose alarm limit as the user'sinsulin load increases to high level. In another example, both the lowglucose alarm limit and the high glucose alarm limit can be adjusted inresponse to the user's insulin load decreasing to a low level.

Third, particular embodiments of the infusion pump system can beconfigured to provide an alarm when the user's insulin load informationor the user's blood glucose data indicate that a bolus dosage wasmissed. In some circumstances, the pump controller can receive bloodglucose information from a glucose monitoring device worn by the user.The pump controller can process this blood glucose data along withinsulin delivery data to determine if conditions indicate that the userskipped a bolus delivery (e.g., the user consumed a meal withoutactivating a meal bolus or another scenario). In response to suchconditions, the infusion pump controller can provide an alarm to theuser indicating the missed bolus dosage and then prompt the user to takecorrective actions. In some circumstances, the pump controller canemploy the user's insulin load data to confirm whether conditionsindicate that the user skipped a bolus delivery (and thereafter providean alarm to the user indicating the missed bolus dosage).

Fourth, some embodiments of the infusion pump system can be configuredto provide an alarm when the user's insulin load information or theuser's blood glucose data indicate that a scheduled meal (or other foodintake) was not consumed. For example, the pump controller may processthe user's blood glucose data (e.g., received from a monitoring deviceworn by the user) to determine if conditions indicate that the userskipped a scheduled meal (or other food intake). In response to suchconditions, the infusion pump controller can provide an alarm to theuser indicating the missed meal and can prompt the user to takecorrective actions. In another example, the pump controller can processthe user's insulin load data to determine if conditions indicate thatthe user skipped a scheduled meal (or other food intake).

The details of one or more embodiments of the invention are set forth inthe accompanying drawings and the description below. Other features,objects, and advantages of the invention will be apparent from thedescription and drawings, and from the claims.

DESCRIPTION OF DRAWINGS

FIG. 1 is a perspective view of an infusion pump system in accordancewith some embodiments.

FIG. 2 is a perspective exploded view of an infusion pump assembly ofthe system of FIG. 1.

FIG. 3 is a perspective view of the infusion pump system of FIG. 1 inwhich the pump assembly is worn on clothing of a user, in accordancewith particular embodiments.

FIG. 4 is a perspective view of an infusion pump system of FIG. 1 inwhich the pump assembly is worn on skin of a user, in accordance withother embodiments.

FIGS. 5-6 are perspective views of a pump device being detached from acontroller device of the system of FIG. 1, in accordance with someembodiments.

FIGS. 7-8 are perspective views of the pump device of FIGS. 5-6 beingdiscarded and the controller device of FIGS. 5-6 being reused with a newpump device.

FIG. 9 is an exploded perspective view of a controller device for aninfusion pump system, in accordance with some embodiments.

FIG. 10 is a perspective view of a portion of a pump device for aninfusion pump system, in accordance with particular embodiments.

FIG. 11 is a flow diagram depicting an exemplary process used todetermine a user's total insulin load (TIL), in accordance with someembodiments.

FIG. 12 is a diagram depicting an example of an insulin decay curve,which may be employed in the determination of the user's TIL inaccordance with some embodiments.

FIG. 13 is a diagram depicting an example of an insulin delivery pattern(constant basal delivery rate only) and a user's corresponding TIL andTIL % values, in accordance with some embodiments.

FIG. 14 is a diagram depicting an example of an insulin delivery pattern(constant basal delivery rate plus selected bolus deliveries) and auser's corresponding TIL and TIL % values, in accordance with someembodiments.

FIG. 15 is a diagram depicting an example of an insulin delivery pattern(intermittent basal delivery plus selected bolus deliveries) andcorresponding TIL and TIL %, in accordance with some embodiments.

FIG. 16A is a diagram depicting an example of an insulin deliverypattern (intermittent basal delivery plus selected bolus deliveries) anda user's corresponding TIL and TIL % values, in accordance with someembodiments.

FIG. 16B is a diagram depicting an example of insulin delivery pattern(intermittent basal delivery plus selected bolus deliveries) and auser's corresponding TIL and TIL % values that account for a previouslyconsumed food component, in accordance with some embodiments.

FIG. 17 is a flow diagram depicting an exemplary process used todetermine, and alert a user of, high or low blood glucose levels, inresponse to TIL information, in some embodiments.

FIG. 18 is a flow diagram depicting an exemplary process used to modifyhigh and low blood glucose alarm limits, in response to TIL values, insome embodiments.

FIG. 19 is a flow diagram depicting an exemplary process used to modifyhigh and low blood glucose alarm limits, in response to TIL % values, insome embodiments.

FIG. 20 is a diagram depicting three exemplary TIL ranges and thecorresponding normal blood glucose ranges, in some embodiments.

FIG. 21 is a flow diagram depicting an exemplary process used to modifyhigh and low blood glucose alarm limits, in response to TIL values, insome embodiments.

FIG. 22 is a diagram depicting an exemplary blood glucose curve,including a missed bolus, and the corresponding 2nd derivative of thatcurve.

FIG. 23 is a flow diagram depicting an exemplary process used toidentify a missed bolus using blood glucose information, in someembodiments.

FIG. 24 is a diagram depicting an exemplary blood glucose curve,including a missed meal, and the corresponding 2nd derivative of thatcurve.

FIG. 25 is a flow diagram depicting an exemplary process used toidentify a missed meal using blood glucose information, in someembodiments.

Like reference symbols in the various drawings indicate like elements.

DETAILED DESCRIPTION

Referring to FIG. 1, an infusion pump system 10 can include a pumpassembly 60 used to supply insulin or other medication to a user via,for example, an infusion set 70. In some embodiments, a glucosemonitoring device 50 can be in communication with the infusion pumpassembly 60 for the purpose of supplying data indicative of a user'sblood glucose level to a controller device 200 included in the pumpassembly 60. The infusion pump system 10 can utilize the data indicativeof a user's blood glucose level to, for example, provide an alarm (e.g.,an audible or textual safety alarm, an audible or textual alertnotification, or another type of alarm) when the user's blood glucoselevel falls below a low glucose alarm limit or rises above a highglucose alarm limit.

In some embodiments, the infusion pump system 10 can be configured tosupply scheduled basal dosages of insulin (or other medication) alongwith user-selected bolus dosages. The basal rate can be selected tomaintain a user's blood glucose level in a target range during normalactivity when the user is not eating or otherwise consuming food items.The selected bolus deliveries may provide substantially larger amountsof insulin to limit the blood glucose level during certaincircumstances, such as the consumption of carbohydrates and other fooditems. Due in part to pharmacokinetic effects (e.g., the time it takesfor insulin to enter the blood stream from the subcutaneous point ofdelivery) and pharmacodynamic effects (e.g., the time it takes for aconcentration of insulin in the blood to have the physiological effectof lower blood glucose level), basal and bolus insulin dispensed intothe user's system may not act instantaneously, but instead may act overa period of time to control the user's blood glucose level. As such, theuser's body may include some amount of insulin that has not yet actedeven while the infusion pump assembly 60 is activated to deliveradditional dosages (basal, bolus, or a combination thereof). In thesecircumstances, the infusion pump assembly 60 can be used to determine auser's insulin load, which can provide an estimate of the insulin whichhas been delivered but has not yet acted in the user's body. Asdescribed herein, the phrase “insulin load” can include an estimatepreviously dispensed insulin, such as the sum of recent bolus activity,and may preferably include an estimated value of previously dispensedinsulin that has not yet acted in the user's body, such as total insulinload (TIL) information (a more comprehensive determination as describedin more detail below), traditional insulin-on-board estimates (whichtypically account for only bolus dosages), or other such estimatedinsulin load values.

In some embodiments, the controller device 200 can determine a user'sTIL information (e.g., a user's TIL value, TIL % value, or the like) ina manner that accounts for both the bolus deliveries and the basaldeliveries (not merely bolus deliveries alone, as is typical withinsulin-on-board estimations). As described in more detail below, thisprocess for determining a user's TIL value can accurately reflect basalrate changes and bolus infusions. For example, in some embodiments, auser's can have different basal rates depending on the time of day(e.g., a higher basal rate during some parts of the day, a lower basalrate during the night, etc.) In further embodiments, the TIL informationcan be determined by the controller device 200 in a manner that alsoaccounts for the user's previously consumed food (along with theprevious basal and bolus deliveries). As described in more detail below,such a process for determining the TIL information can quantify both thepreviously dispensed insulin that has not yet acted on the user and thepreviously consumed food that has not yet been metabolized.

In some embodiments, data related to a user's insulin load, such as TILvalues (or insulin-on-board estimates) and the times at which they werecalculated, can be stored in a memory device (described below) of thecontroller device 200. This data can be used, for example, by thecontroller device 200 in a process to modify particular glucose alarmlimits (e.g., the high glucose alarm limit, the low glucose alarm limit,or other alarm limits employed by the controller device 200). Generally,if a user's insulin load is lower than normal, the chances of the user'sblood glucose level rising is more likely. In these circumstances, thecontroller device 200 may provide enhanced user safety by reducing thehigh glucose alarm limit, which can alert the user to a potentiallydangerous increase in blood glucose level sooner than if the highglucose alarm limit was not modified. Alternatively, when the user'sinsulin load value is higher than normal or there has been recent bolusactivity, the chances of the user's blood glucose level rising is lesslikely. In these circumstances, the controller device 200 may reduce thelikelihood of nuisance alarms by raising the high glucose alarm limit orincreasing the delay time between consecutive alarms, any of which canprovide additional convenience to the user. In one example, a user witha default high glucose alarm limit of 200 mg/dL may have a current bloodglucose level of 170 mg/dL. If that user has an insulin load (e.g., aTIL value, an IOB estimation, or the like) that is lower than a normalvalue or range (which may indicate the user's blood glucose level couldrise in the near future, the controller device 200 may be configured totemporarily lower the high glucose alarm limit to, for example, 180mg/dl to more quickly identify potentially unsafe rises in the user'sblood glucose level.

In some embodiments, the user's blood glucose information can be used toprovide alarms (including safety alarms, alert notifications, or thelike) indicating an event other than “high” or “low” blood glucoselevels. For example, when receiving data indicative of a user's bloodglucose levels, on a periodic basis, from the monitoring device 50, thecontroller device 200 can be configured to provide one or more of amissed bolus alarm and a missed meal alarm (described below inconnection with FIGS. 22-25). For example, the controller device 200 candetermine from the stored blood glucose values that conditions indicatea user experienced a “missed bolus” situation or a “missed meal”situation. Identifying a “missed meal” and/or “missed bolus” situationcan benefit the user in that this information can be used by thecontroller device 200 to prompt corrective action (e.g., prompting theuser to eat, prompting the user for input in order to suggest a bolusdosage, or the like) before the user's blood glucose level has risen orfallen out of a normal range.

Still referring to FIG. 1, the glucose monitoring device 50 can includea housing 52, a wireless communication device 54, and a sensor shaft 56.The wireless communication device 54 can be contained within the housing52 and the sensor shaft 56 can extend outward from the housing 52. Inuse, the sensor shaft 56 can penetrate the skin 20 of a user to makemeasurements indicative of characteristics of the user's blood (e.g.,the user's blood glucose level or the like). In response to themeasurements made by the sensor shaft 56, the glucose monitoring device50 can employ the wireless communication device 54 to transmit data tothe controller device 200 of the pump assembly 60.

In some embodiments, the monitoring device 50 may include a circuit thatpermits sensor signals (e.g., data from the sensor shaft 56) to becommunicated to the communication device 54. The communication device 54can transfer the collected data to the infusion pump assembly 60 (e.g.,by wireless communication to a communication device 247 arranged in thepump assembly 60). In some embodiments, the monitoring device 50 canemploy other methods of obtaining information indicative of a user'sblood characteristics and transferring that information to the infusionpump assembly 60. For example, an alternative monitoring device mayemploy a micropore system in which a laser porator creates tiny holes inthe uppermost layer of a user's skin, through which interstitial glucoseis measured using a patch. Alternatively, the monitoring device can useiontophoretic methods to non-invasively extract interstitial glucose formeasurement. In other examples, the monitoring device can includenon-invasive detection systems that employ near IR, ultrasound orspectroscopy, and particular embodiments of glucose-sensing contactlenses. Invasive methods involving optical means of measuring glucosecould also be added. In yet another example, the monitoring device caninclude an optical detection instrument that is inserted through theskin for measuring the user's glucose level.

Furthermore, it should be understood that in some embodiments, themonitoring device 50 can be in communication with the pump assembly 60via a wired connection. In other embodiments of the pump system 10, teststrips (e.g., blood test strips) containing a sample of the user's bloodcan be inserted into a strip reader portion of the pump assembly 60 tobe tested for characteristics of the user's blood. Alternatively, thetest strips (e.g., glucose test strips) containing a sample of theuser's blood can be inserted into a glucose meter device (not shown inFIG. 1), which then analyzes the characteristics of the user's blood andcommunicates the information (via a wired or wireless connection) to thepump assembly 60. In still other embodiments, characteristics of theuser's blood glucose information can be entered directly into the pumpsystem 10 via a user interface on the controller device 200.

Referring now to FIGS. 1-2, the infusion pump assembly 60 can include apump device 100 and the controller device 200 that communicates with thepump device 100. The pump device 100 includes a housing structure 110that defines a cavity 116 in which a fluid cartridge 120 can bereceived. The pump device 100 also includes a cap device 130 to retainthe fluid cartridge 120 in the cavity 116 of the housing structure 110.The pump device 100 includes a drive system (described in more detailbelow in connection with FIG. 10) that advances a plunger 125 in thefluid cartridge 120 so as to dispense fluid therefrom. In someembodiments, the dispensed fluid exits the fluid cartridge 120, passesthrough a flexible tube 72 of the infusion set 70 to a cannula housing74. The dispensed fluid can enter through the skin via a cannula 76attached to the underside of the cannula housing 74.

In some embodiments, the controller device 200 communicates with thepump device 100 to control the operation of the pump drive system. Whenthe controller device 200, the pump device 100 (including the cap device130 in this embodiment), and the fluid cartridge 120 are assembledtogether, the user may conveniently wear the infusion pump assembly 60on the user's skin under clothing or in the user's pocket whilereceiving the fluid dispensed from the pump device 100 (refer, forexample, to FIGS. 3-4). Thus, in some embodiments, the pump assembly canoperate as a portable unit that provides reliable delivery of insulin oranother medication in a discrete manner.

As described in more detail below, the controller device 200 may beconfigured as a reusable component that provides electronics and a userinterface to control the operation of the pump device 100. In suchcircumstances, the pump device 100 can be a disposable component that isdisposed of after a single use. For example, the pump device 100 can bea “one time use” component that is thrown away after the fluid cartridge120 therein is exhausted. Thereafter, the user can removably attach anew pump device 100 to the reusable controller device 200 for thedispensation of fluid from a new fluid cartridge 120. Accordingly, theuser is permitted to reuse the controller device 200 (which may includecomplex or valuable electronics) while disposing of the relativelylow-cost pump device 100 after each use. Such a pump assembly 60 canprovide enhanced user safety as a new pump device 100 (and drive systemtherein) is employed with each new fluid cartridge 120.

Briefly, in use, the pump device 100 can be configured to removablyattach to the controller device 200 in a manner that provides a securefitting, an overall compact size, and a reliable electrical connection.The compact size permits the infusion pump assembly 60 to be discreteand portable. As described in more detail below, the controller device200 of the infusion pump system can be used to provide glucose alarmsindicative of high and low blood glucose levels (when compared topredetermined high and low blood glucose alarm levels, respectively),modify predetermined high and low blood glucose alarm levels based oninsulin load information (e.g., TIL, insulin-on-board, TIL % value, andthe like), and/or determine missed meal and missed bolus situations.

It should be understood that, in alternative embodiments, the pumpdevice 100 and the controller device 200 can be configured as a singleunit in which the control components and the pump drive system arearranged in a single housing. In these alternative embodiments, the pumpassembly (including the controller device and the pump device) may havea different size and shape and may operate as a reusable unit that cancommunicate with a number of monitoring devices 50 over a period oftime.

Referring again to FIGS. 1-2, in some embodiments, the pump system 10 isa medical infusion pump system that is configured to controllablydispense a medicine from the cartridge 120. As such, the fluid cartridge120 may contain a medicine 126 to be infused into the tissue orvasculature of a targeted individual, such as a human or animal patient.For example, the pump device 100 can be adapted to receive a medicinecartridge 120 in the form of a carpule that is preloaded with insulin oranother medicine for use in the treatment of Diabetes (e.g., Byetta®,Symlin®, or others). Such a cartridge 120 may be supplied, for example,by Eli Lilly and Co. of Indianapolis, Ind. Other examples of medicinescontained in the fluid cartridge 120 include: medicines to treat primaryimmune deficiency (e.g., Vivaglobin® by CSL Behring of King of Prussia,Pa.), pain relief drugs, hormone therapy, blood pressure treatments,anti-emetics, osteoporosis treatments, or other injectable medicines.The medicine dispensed from the cartridge 120 into the user's system mayact over a period of time in the user's body. As such, the user's bodymay include some amount of medicine that has not yet acted even whilethe infusion pump assembly 60 is activated to deliver additional dosagesof the medicine (basal, bolus, or both). The infusion pump assembly 60can be used to determine a user's total medicine load that provides anaccurate indication of the medicine which has not yet acted in theuser's body. The total medicine load can be determined by the controllerdevice 200 in a manner that accounts for both the bolus deliveries andthe basal deliveries of the medicine (similar to the process fordetermining the total insulin load as described below). It should beunderstood from the description herein that the fluid cartridge 120 mayhave a configuration other than that depicted in FIG. 2. For example,the fluid cartridge may have a different outer shape or a differentreservoir volume. In another example, the fluid cartridge may comprise areservoir that is integral with the pump housing structure 110 (e.g.,the fluid cartridge can be defined by one or more walls of the pumphousing structure 110 that surround a plunger to define a reservoir inwhich the medicine is injected or otherwise received).

In some embodiments, the pump device 100 may include one or morestructures that interfere with the removal of the medicine cartridge 120after the medicine cartridge 120 is inserted into the cavity 116. Forexample, as shown in FIG. 2, the pump housing structure 110 may includeone or more retainer wings 119 that at least partially extend into thecavity 116 to engage a portion of the medicine cartridge 120 when themedicine cartridge 120 is installed therein. In this embodiment, thepump housing structure 110 includes a pair of opposing retainer wings119 (only one is shown in the view in FIG. 2) that flex toward the innersurface of the cavity 116 during insertion of the medicine cartridge120. After the medicine cartridge is inserted to a particular depth, theretainer wings 119 are biased to flex outward (toward the center of thecavity 116) so that the retainer wings 119 engage a neck portion 129 ofthe medicine cartridge 120. This engagement with the retainer wings 119and the neck portion 129 hinder any attempts to remove the medicinecartridge 120 away from the pump device 100. Alternative embodiments caninclude other features and/or configurations to hinder the removal ofthe medicine cartridge 120.

Embodiments of the pump device 100 that hinder the removal of themedicine cartridge 120 may facilitate the “one-time-use” feature of thepump device 100. Because the retainer wings 119 can interfere withattempts to remove the medicine cartridge 120 from the pump device 100,the pump device 100 will be discarded along with the medicine cartridge120 after the medicine cartridge 120 is emptied, expired, or otherwiseexhausted. The retainer wings 119 may serve to hinder attempts to removethe exhausted medicine cartridge 120 and to insert a new medicinecartridge 120 into the previously used pump device 100. Accordingly, thepump device 100 may operate in a tamper-resistant and safe mannerbecause the pump device 100 can be designed with predetermined lifeexpectancy (e.g., the “one-time-use” feature in which the pump device isdiscarded after the medicine cartridge 120 is emptied, expired, orotherwise exhausted).

Still referring to FIGS. 1-2, the cap device 130 can be joined with thepump device 100 after the medicine cartridge is inserted in the cavity116. It should be understood that the cap device 130 may supplement orreplace the previously described retainer wings 119 by locking intoposition after joining with the pump housing 110, thereby hinderingremoval of the fluid cartridge 120 in the pump housing 110. As shown inFIGS. 1-2, the cap device 130 may include an output port 139 thatconnects with the tubing 72 for dispensation of the medicine to theuser. In some embodiments, the output port 139 may have an angledorientation such that a portion of the tubing extends transversely tothe central axis of the cartridge 120 and cap device 130. The outputport 139 can be configured to mate with tubing 72 of the infusion set 70(FIG. 1).

In some embodiments, the controller device 200 may be removably attachedto the pump device 100 so that the two components are mechanicallymounted to one another in a fixed relationship. Such a mechanicalmounting can form an electrical connection between the removablecontroller device 200 and the pump device 100. For example, thecontroller device 200 may be in electrical communication with a portionof a drive system (described in connection with FIG. 10) of the pumpdevice 100. As described in more detail below, the pump device 100includes a drive system that causes controlled dispensation of themedicine or other fluid from the cartridge 120. In some embodiments, thedrive system incrementally advances a piston rod longitudinally into thecartridge 120 so that the fluid is forced out of an output end 122. Theseptum 121 at the output end 122 of the fluid cartridge 120 can bepierced to permit fluid outflow when the cap device 130 is connected tothe pump housing structure 110. Thus, when the pump device 100 and thecontroller device 200 are attached and thereby electrically connected,the controller device 200 communicates electronic control signals via ahardwire-connection (e.g., electrical contacts or the like) to the drivesystem or other components of the pump device 100. In response to theelectrical control signals from the controller device 200, the drivesystem of the pump device 100 causes medicine to incrementally dispensefrom the medicine cartridge 120.

The controller device 200 may be configured to removably attach to thepump device 100, for example, in a side-by-side arrangement. The compactsize permits the infusion pump assembly 60 to be discrete and portablewhen the pump device 100 is attached with the controller device 200 (asshown in FIG. 1). In this embodiment, the controller device 200 includesa controller housing structure 210 having a number of features that areconfigured to mate with complementary features of the pump housingstructure 110 so as to form a releasable mechanical connection(described below in more detail in connection with FIGS. 5-7). Suchmating features of the pump housing structure 110 and the controllerhousing structure 210 can provide a secure connection when thecontroller device 200 is attached to the pump device 100

As shown in FIG. 2, the pump device 100 may include an electricalconnector 118 (e.g., having conductive pads, pins, or the like) that areexposed to the controller device 200 and that mate with a complementaryelectrical connector (refer to connector 218 in FIG. 6) on the adjacentface of the controller device 200. The electrical connectors 118 and 218provide the electrical communication between the control circuitry(refer, for example, to FIG. 9) housed in the controller device 200 andat least a portion of the drive system or other components of the pumpdevice 100. In some exemplary embodiments, the electrical connectors 118and 218 permit the transmission of electrical control signals to thepump device 100 and the reception of feedback signals (e.g., sensorsignals) from particular components within the pump device 100.Furthermore, as described in more detail below, the infusion pumpassembly 60 may include a gasket 140 that provides a seal which isresistant to migration of external contaminants when the pump device 100is attached to the controller device 200. Thus, in some embodiments, thepump device 100 and the controller device 200 can be assembled into awater resistant configuration that protects the electricalinterconnection from water migration (e.g., if the user encounters waterwhile carrying the pump assembly 60).

Referring again to FIGS. 1-2, the controller device 200 includes theuser interface 220 that permits a user to monitor the operation of thepump device 100. In some embodiments, the user interface 220 includes adisplay 222 and one or more user-selectable buttons (e.g., four buttons224 a, 224 b, 224 c, and 224 d in this embodiment). The display 222 mayinclude an active area in which numerals, text, symbols, images, or acombination thereof can be displayed (refer, for example, to FIG. 2).For example, the display 222 may be used to communicate a number ofstatus indicators, alarms, settings, and/or menu options for theinfusion pump system 10. In some embodiments, the display 222 canindicate an alarm indicative of a high or low blood glucose level, highor low insulin load, the user's current TIL information, the user'sblood glucose level, an indication that the user's blood glucose levelis rising or falling, an indication that a blood glucose alarm level wasmodified, and the like. In the example depicted in FIG. 1, the display222 indicates that the user has a low insulin load, with a calculatedTIL level of 0.5 units, and one or more glucose alarm limits have beendecreased. In this embodiment, the display 222 also indicates that theuser's blood glucose level is currently at 180 mg/dl and is rising.

In some embodiments, the user may press one or more of the buttons 224a, 224 b, 224 c, and 224 d to shuffle through a number of menus orprogram screens that show particular status indicators, settings, and/ordata (e.g., review data that shows the medicine dispensing rate, thetotal amount of medicine dispensed in a given time period, the amount ofmedicine scheduled to be dispensed at a particular time or date, theapproximate amount of medicine remaining in the cartridge 120, or thelike). In some embodiments, the user can adjust the settings orotherwise program the controller device 200 by pressing one or morebuttons 224 a, 224 b, 224 c, and 224 d of the user interface 220. Forexample, in embodiments of the infusion pump system 10 configured todispense insulin, the user may press one or more of the buttons 224 a,224 b, 224 c, and 224 d to change the dispensation rate of insulin or torequest that a bolus of insulin be dispensed immediately or at ascheduled, later time.

The display 222 of the user interface 220 may be configured to displayalarm information when no buttons 224 a, 224 b, 224 c, and 224 d havebeen pressed. For example, as shown in FIG. 2, the active area of thedisplay 222 can display an alert indicating that the user's insulin loadis high, the user's current TIL information (a 4.2 unit load in thisexample), and that the low glucose alarm level has been increased (e.g.,in response to the high TIL value). The display 222 can also display theuser's blood glucose level (99 mg/dl in this example) and an indicationof whether the user's blood glucose level is rising or falling (thedownward facing arrow indicates a falling glucose level in thisexample). This information can be displayed until one of the buttons 224a, 224 b, 224 c, and 224 d has been actuated. This, or other,information can also be displayed for a period of time after no button224 a, 224 b, 224 c, and 224 d has been actuated (e.g., five seconds, 10seconds, 30 seconds, 1 minute, 5 minutes, or the like). Thereafter, thedisplay 222 may enter sleep mode in which the active area is blank,thereby conserving battery power. In addition or in the alternative, theactive area can display particular device settings, such as the currentdispensation rate or the total medicine dispensed, for a period of timeafter no button 224 a, 224 b, 224 c, or 224 d has been actuated (e.g.,five seconds, 10 seconds, 30 seconds, 1 minute, 5 minutes, or the like).Again, thereafter the display 222 may enter sleep mode to conservebattery power. In certain embodiments, the display 222 can dim after afirst period of time in which no button 224 a, 224 b, 224 c, or 224 dhas been actuated (e.g., after 15 seconds or the like), and then thedisplay 22 can enter sleep mode and become blank after a second periodof time in which no button 224 a, 224 b, 224 c, or 224 d has beenactuated (e.g., after 30 seconds or the like). Thus, the dimming of thedisplay device 222 can alert a user viewing the display device 222 whenthe active area 223 of the display device will soon become blank.

Accordingly, when the controller device 200 is connected to the pumpdevice 100, the user is provided with the opportunity to readily monitorinfusion pump operation by simply viewing the display 222 of thecontroller device 200. Such monitoring capabilities may provide comfortto a user who may have urgent questions about the current operation ofthe pump device 100 (e.g., the user may be unable to receive immediateanswers if wearing an infusion pump device having no user interfaceattached thereto). Moreover, the TIL information can be displayedcontemporaneously with the detected blood glucose value, so the user isprovided with the opportunity to make informed decisions regarding thecurrent and future status of his or her blood glucose level.

Also, in these embodiments, there may be no need for the user to carryand operate a separate module to monitor the operation of the infusionpump device 100, thereby simplifying the monitoring process and reducingthe number of devices that must be carried by the user. If a need arisesin which the user desires to monitor the operation of the pump device100 or to adjust settings of the pump system 10 (e.g., to request abolus amount of medicine), the user can readily operate the userinterface 220 of the controller device 200 without the requirement oflocating and operating a separate monitoring module.

In other embodiments, the user interface 200 is not limited to thedisplay and buttons depicted in FIGS. 1-2. For example, in someembodiments, the user interface 220 may include only one button or mayinclude a greater numbers of buttons, such as two buttons three buttons,four buttons, five buttons, or more. In another example, the userinterface 220 of the controller device 200 may include a touch screen sothat a user may select buttons defined by the active area of the touchscreen display. Alternatively, the user interface 220 may comprise audioinputs or outputs so that a user can monitor the operation of the pumpdevice 100.

Referring to FIGS. 3-4, the infusion pump system 10 may be configured tobe portable and can be wearable and concealable. For example, a user canconveniently wear the infusion pump assembly 60 on the user's skin(e.g., skin adhesive) underneath the user's clothing or carry the pumpassembly 60 in the user's pocket (or other portable location) whilereceiving the medicine dispensed from the pump device 100. The pumpdevice 100 may be arranged in a compact manner so that the pump device100 has a reduced length. For example, in the circumstances in which themedicine cartridge 120 has a length of about 7 cm or less, about 6 cm toabout 7 cm, and about 6.4 cm in one embodiment, the overall length ofthe pump housing structure 110 (which contains medicine cartridge andthe drive system) can be about 10 cm or less, about 7 cm to about 9 cm,and about 8.3 cm in one embodiment. In such circumstances, thecontroller device 200 can be figured to mate with the pump housing 110so that, when removably attached to one another, the components define aportable infusion pump system that stores a relatively large quantity ofmedicine compared to the overall size of the unit. For example, in thisembodiment, the infusion pump assembly 60 (including the removablecontroller device 200 attached to the pump device 100 having the cap130) may have an overall length of about 11 cm or less, about 7 cm toabout 10 cm, and about 9.6 cm in one embodiment; an overall height ofabout 6 cm or less, about 2 cm to about 5 cm, and about 4.3 cm in oneembodiment; and an overall thickness of about 20 mm or less, about 8 mmto about 20 mm, and about 18.3 mm in one embodiment.

The pump system 10 is shown in FIGS. 3-4 is compact so that the user canwear the portable infusion pump system 10 (e.g., in the user's pocket,connected to a belt clip, adhered to the user's skin, or the like)without the need for carrying and operating a separate module. In suchembodiments, the cap device 130 of the pump device 100 may be configuredto mate with the infusion set 70. In general, the infusion set 70 istubing system that connects the infusion pump system 10 to the tissue orvasculature of the user (e.g., to deliver medicine into the user'ssubcutaneous tissue or vasculature). The infusion set 70 may include theflexible tube 72 that extends from the pump device 100 to thesubcutaneous cannula 76 retained by a skin adhesive patch 78 thatsecures the subcutaneous cannula 76 to the infusion site. The skinadhesive patch 78 can retain the infusion cannula 76 in fluidcommunication with the tissue or vasculature of the patient so that themedicine dispensed through the tube 72 passes through the cannula 76 andinto the user's body. The cap device 130 may provide fluid communicationbetween the output end 122 (FIG. 2) of the medicine cartridge 120 andthe tube 72 of the infusion set 70. For example, the tube 72 may bedirectly connected to the output port 139 (FIG. 2) of the cap device130. In another example, the infusion set 70 may include a connector(e.g., a Luer connector or the like) attached to the tube 72, and theconnector can then mate with the cap device 130 to provide the fluidcommunication to the tube 72. In these examples, the user can carry theportable infusion pump assembly 60 (e.g., in the user's pocket,connected to a belt clip, adhered to the user's skin, or the like) whilethe tube 72 extends to the location in which the skin is penetrated forinfusion. If the user desires to monitor the operation of the pumpdevice 100 or to adjust the settings of the infusion pump system 10, theuser can readily access the user interface 220 of the controller device200 without the need for carrying and operating a separate module.

Referring to FIG. 3, in some embodiments, the infusion pump assembly 60is pocket-sized so that the pump device 100 and controller device 200can be worn in the user's pocket 6 or in another portion of the user'sclothing. For example, the pump device 100 and the controller device 200can be attached together and form the assembly 60 that comfortably fitsinto a user's pocket 6. The user can carry the portable infusion pumpassembly 60 and use the tube 72 of the infusion set 70 to direct thedispensed medicine to the desired infusion site. In some circumstances,the user may desire to wear the pump assembly 60 in a more discretemanner. Accordingly, the user may pass the tube 72 from the pocket 6,under the user's clothing, and to the infusion site where the adhesivepatch 78 is positioned. As such, the pump system 10 can be used todeliver medicine to the tissues or vasculature of the user in aportable, concealable, and discrete manner. Furthermore, the monitoringdevice 50 can be worn on the user's skin while the pump assembly 60 iscarried by the user (e.g., in a pocket). As such, the monitoring device50 can communicate information indicative of the user's blood glucoselevel to the pump assembly 60 while the pump assembly 60 is used todeliver medicine through the infusion set 70. In this embodiment, themonitoring device 50 may be arranged on the user's skin at a locationthat is spaced apart from the infusion set 70.

Referring to FIG. 4, in other embodiments, the infusion pump assembly 60may be configured to adhere to the user's skin 7 directly at thelocation in which the skin is penetrated for medicine infusion. Forexample, a rear surface of the pump device 100 may include a skinadhesive patch so that the pump device 100 is physically adhered to theskin of the user at a particular location. In these embodiments, the capdevice 130 may have a configuration in which medicine passes directlyfrom the cap device 130 into an infusion cannula 76 that is penetratedinto the user's skin. In one example, the fluid output port 139 throughthe cap device 130 can include a curve or a 90° corner so that themedicine flow path extends longitudinally out of the medicine cartridgeand thereafter laterally toward the patient's skin 7. Again, if the userdesires to monitor the operation of the pump device 100 or to adjust thesettings of the infusion pump system 10, the user can readily access theuser interface 220 of the controller device 200 without the need forcarrying and operating a second, separate device. For example, the usermay look toward the pump device 100 to view the user interface 220 ofthe controller device 200 that is removably attached thereto. In anotherexample, the user can temporarily detach the controller device 200(while the pump device 100 remains adhered to the skin 7) so as to viewand interact with the user interface 220. Furthermore, the monitoringdevice 50 can be worn on the user's skin while the pump assembly 60 isworn on the user's skin in a different location from that where themonitoring device is worn. As such, the monitoring device 50 cancommunicate information indicative of the user's blood glucose level tothe pump assembly 60 while the pump assembly 60 is used to delivermedicine through the infusion set 70. In this embodiment, the monitoringdevice 50 may be arranged on the user's skin at a location that isspaced apart from the infusion set 70.

In the embodiments depicted in FIGS. 3-4, the monitoring device 50adheres to the user's skin 7 at the location in which the skin ispenetrated by the sensor shaft 56 (to detect blood glucose levels). Thesensor shaft 56 (refer to FIG. 1) penetrates the skin surface for thepurpose of exposing the tip portion of the sensor shaft 56 to the tissueor the vasculature of the user. The sensor shaft 56 can detectinformation indicative of the user's blood glucose level and transferthis information to a circuit that is connected to the communicationsdevice 54 located within the monitoring device 50. The communicationdevice 54 can be in wireless communication with the communication device247 (described in connection with FIG. 9) included in the controllerdevice 200 of the pump assembly 60.

Referring now to FIGS. 5-8, in some embodiments, the infusion pumpassembly 60 can be operated such that the pump device 100 is adisposable, non-reusable component while the controller device 200 is areusable component. In these circumstances, the pump device 100 may beconfigured as a “one-time-use” device that is discarded after themedicine cartridge is emptied, expired, or otherwise exhausted. Thus, insome embodiments, the pump device 100 may be designed to have anexpected operational life of about 1 day to about 30 days, about 1 dayto about 20 days, about 1 to about 14 days, or about 1 day to about 7days—depending on the volume of medicine in the cartridge 120, thedispensation patterns that are selected for the individual user, andother factors. For example, in some embodiments, the medicine cartridge120 containing insulin may have an expected usage life about 7 daysafter the cartridge is removed from a refrigerated state and the septum121 (FIG. 2) is punctured. In some circumstances, the dispensationpattern selected by the user can cause the insulin to be emptied fromthe medicine cartridge 120 before the 7-day period. If the insulin isnot emptied from the medicine cartridge 120 after the 7-day period, theremaining insulin may become expired sometime thereafter. In eithercase, the pump device 100 and the medicine cartridge 120 therein can bediscarded after exhaustion of the medicine cartridge 120 (e.g., afterbeing emptied, expired, or otherwise not available for use).

The controller device 200, however, may be reused with subsequent newpump devices 100′ and new medicine cartridges 120′. As such, the controlcircuitry, the user interface components, and other components that mayhave relatively higher manufacturing costs can be reused over a longerperiod of time. For example, in some embodiments, the controller device200 may be designed to have an expected operational life of about 1 yearto about 7 years, about 2 years to about 6 years, or about 3 years toabout 5 years—depending on a number of factors including the usageconditions for the individual user. Accordingly, the user is permittedto reuse the controller device 200 (which may include complex orvaluable electronics) while disposing of the relatively low-cost pumpdevice 100 after each use. Such a pump system 10 can provide enhanceduser safety as a new pump device 100′ (and drive system therein) isemployed with each new fluid cartridge 120.

Referring to FIGS. 5-6, the pump device 100 can be readily removed fromthe controller device 200 when the medicine cartridge 120 is exhausted.As previously described, the medicine cartridge 120 is arranged in thecavity 116 (FIG. 2) of the pump housing 110 where it is retained by thecap device 130. In some embodiments, a portion of the pump housing 110can comprise a transparent or translucent material so that at least aportion of the medicine cartridge 120 is viewable therethrough. Forexample, the user may want to visually inspect the medicine cartridgewhen the plunger 125 is approaching the output end 122 of the medicinecartridge, thereby providing a visual indication that the medicinecartridge may be emptied in the near future. In this embodiment, thebarrel 111 of the pump housing 110 comprises a generally transparentpolymer material so that the user can view the medicine cartridge 120 todetermine if the plunger 125 is nearing the end of its travel length.

As shown in FIG. 5, the pump device 100 has been used to a point atwhich the medicine cartridge 120 is exhausted. The plunger 125 has beenadvanced, toward the left in FIG. 5, over a period of time so that allor most of the medicine has been dispensed from the cartridge 120. Insome embodiments, the controller device 200 may provide a visual oraudible alert when this occurs so as to remind the user that a newmedicine cartridge is needed. In addition or in the alternative, theuser may visually inspect the medicine cartridge 120 through the barrel111 of the pump housing 110 to determine if the medicine cartridge 120is almost empty. When the user determines that a new medicine cartridge120 should be employed, the pump device 100 can be readily separatedfrom the controller device 200 by actuating a release member 215. Inthis embodiment, the release member 215 is a latch on the controllerdevice 200 that is biased toward a locking position to engage the pumpdevice 100. The latch may be arranged to engage one or more features ona lateral side of the pump housing 110. As such, the user may actuatethe release member 215 by moving the release member 215 in a lateraldirection 216 (FIG. 5) away from the pump device 100 (e.g., by applyinga force with the user's finger).

As shown in FIG. 6, when the release member 215 is actuated and moved toa position away from the pump device 100, a segmented guide rail 114 a-bis free to slide longitudinally in a guide channel 214 a-b withoutinterference from the release member 215. Accordingly, the user can movethe pump device 100 in a longitudinal direction 217 away from thecontroller device 200. For example, the segmented guide rail 114 a-b mayslide along the guide channel 214 a-b, the extension 113 (FIG. 2) may bewithdrawn from the mating depression 213 (FIG. 6), and the electricalconnector 118 can be separated from the mating connector 218. In thesecircumstances, the pump device 100 is physically and electricallydisconnected from the controller device 200 while the pump deviceretains the exhausted medicine cartridge 120. It should be understoodthat, in other embodiments, other features or connector devices can beused to facilitate the side-by-side mounting arrangement. These otherfeatures or connector devices may include, for example, magneticattachment devices, mating tongues and grooves, or the like.

In some embodiments, the gasket 140 compressed between the pump device100 and the controller device 200 may comprise a resilient material. Insuch circumstances, the gasket 140 can provide a spring-action thaturges the pump device 100 to shift a small amount away from thecontroller device 200 when the release member 215 is moved to theunlocked position (e.g., moved in the lateral direction 216 in theembodiment shown in FIG. 5). Accordingly, in some embodiments, the pumpdevice 100 can automatically and sharply move a small distance (e.g.,about 0.5 mm to about 5 mm) away from the controller device 200 when therelease member 215 is moved to the unlocked position. Such an automaticseparation provides a convenient start for the user to detach the pumpdevice 100 away from the controller device 200. Furthermore, thisautomatic separation caused by the spring-action of the gasket 140 canprovide a swift disconnect between the electrical connectors 118 and 218when the pump device 100 is being replaced.

Referring to FIGS. 7-8, the same controller device 200 can be reusedwith a new pump device 100′ having a new medicine cartridge 120′retained therein, and the previously used pump device 100 can bediscarded with the exhausted medicine cartridge 120. The new pump device100′ (FIG. 7) can have a similar appearance, form factor, and operationas the previously used pump device 100 (FIGS. 5-6), and thus the newpump device 100′ can be readily attached to the controller device 200for controlled dispensation of medicine from the new medicine cartridge120′. In some embodiments, the user may prepare the new pump device 100′for use with the controller device 200. For example, the user may insertthe new medicine cartridge 120′ in the cavity 116 of the new pump device100′ and then join the cap device 130 to the pump housing to retain thenew medicine cartridge 120′ therein (refer, for example, to FIG. 2).Although the tubing 72 of the infusion set 70 is not shown in FIG. 7, itshould be understood that the tubing 72 may be attached to the capdevice 130 prior to the cap device 130 being joined with the housing110. For example, a new infusion set 70 can be connected to the capdevice 130 so that the tubing 72 can be primed (e.g., a selectedfunction of the pump device 100 controlled by the controller device 200)before attaching the infusion set patch to the user's skin. As shown inFIG. 7, the new medicine cartridge 120′ may be filled with medicine suchthat the plunger 125 is not viewable through the barrel 111. In someembodiments, the user can removably attach the pump device 100 to thecontroller device 200 by moving the pump device 100 in a longitudinaldirection 219 toward the controller device 200 such that the segmentedguide rail 114 a-b engages and slides within the guide channel 214 a-b.When the electrical connectors 118 and 218 mate with one another, therelease member 215 can engage the segmented guide rails 114 a-b toretain the pump device 100 with the controller device 200.

As shown in FIG. 8, the previously used pump device 100 that wasseparated from the controller device (as described in connection withFIGS. 5-6) may be discarded after a single use. In these circumstances,the pump device 100 may be configured as a disposable “one-time-use”device that is discarded by the user after the medicine cartridge 120 isemptied, is expired, has ended its useful life, or is otherwiseexhausted. For example, the pump device 100 may be discarded into a bin30, which may include a trash bin or a bin specifically designated fordiscarded medical products. Thus, the user is permitted to dispose ofthe relatively low-cost pump device 100 after each use while reusing thecontroller device 200 (which may include complex or valuableelectronics) with subsequent new pumps 100′. Also, in somecircumstances, the infusion set 70 (not shown in FIG. 8, refer toFIG. 1) that was used with the pump device 100 may be removed from theuser and discarded into the bin 30 along with the pump device 100.Alternatively, the infusion set 70 can be disconnected from the previouspump device 100 and attached to the new pump device 100′. In thesecircumstances, the user may detach the infusion set cannula 76 and patch78 from the skin so as to “re-prime” the tubing with medicine from thenew pump device 100′ to remove air pockets from the tubing. Thereafter,the infusion set cannula 76 and patch 78 can be again secured to theuser's skin.

Referring now to FIG. 9, the controller device 200 (shown in an explodedview) houses a number of components that can be reused with a series ofsuccessive pump devices 100. In particular, the controller device 200includes control circuitry 240 arranged in the controller housing 210that is configured to communicate control signals to the drive system ofthe pump device 100. In this embodiment, the control circuitry 240includes a main processor board 242 that is in communication with apower supply board 244. The control circuitry 240 includes at least oneprocessor 243 that coordinates the electrical communication to and fromthe controller device 200 (e.g., communication between the controllerdevice 200 and the pump device 100). The processor 243 can be arrangedon the main processor board 242 along with a number of other electricalcomponents such as memory devices (e.g., memory chip 248). It should beunderstood that, although the main processor board 242 is depicted as aprinted circuit board, the main processor board can have other forms,including multiple boards, a flexible circuit substrate, and otherconfigurations that permit the processor 243 to operate. The controlcircuitry 240 can be programmable in that the user may provide one ormore instructions to adjust a number of settings for the operation ofthe infusion pump system 10. Such settings may be stored in the one ormore memory devices, such as the memory chip 248 on the processor board242. The control circuitry 240 may include other components, such assensors (e.g., occlusion sensors), that are electrically connected tothe main processor board 242. Furthermore, the control circuitry 240 mayinclude one or more dedicated memory devices that store executablesoftware instructions for the processor 243. The one or more memorydevices (e.g., the memory chip 248) can also store information relatedto a user's blood glucose level and total insulin load (described inmore detail in association with FIGS. 11-16B) over a period of time.

As previously described, the controller device 200 can be electricallyconnected with the pump device 100 via mating connectors 118 and 218 sothat the control circuitry 240 can communicate control signals to thepump device 100 and receive feedback signals from components housed inthe pump device 100. In this embodiment, the electrical connector 118(FIG. 2) on the pump device 100 is a z-axis connector, and the connector218 (FIG. 6) on the controller device 200 is adapted to mate therewith.The electrical connector 218 on the controller device 200 is incommunication with the control circuitry 240. As such, the processor 243can operate according to software instructions stored in the memorydevice so as to send control signals to the pump device 100 via theconnector 218.

Still referring to FIG. 9, the user interface 220 of the controllerdevice 200 can include input components, output components, or both thatare electrically connected to the control circuitry 240. For example, inthis embodiment, the user interface 220 includes a display device 222having an active area that outputs information to a user and fourbuttons 224 a-d that receive input from the user. Here, the display 222may be used to communicate a number of status indicators, settings,and/or menu options for the infusion pump system 10. In someembodiments, the control circuitry 240 may receive the input commandsfrom the user's button selections and thereby cause the display device222 to output a number of status indicators (e.g., if the pump system 10is delivering insulin, if the user's blood glucose level is rising orfalling, and the like), menus, and/or program screens that showparticular settings and data (e.g., the user's blood glucose level, theuser's insulin load, the user's TIL % value, or the like). As previouslydescribed, the controller circuit 240 can be programmable in that theinput commands from the button selections can cause the controllercircuit 240 to change any one of a number of settings for the infusionpump system 100.

Some embodiments of the control circuitry 240 may include a cableconnector (e.g., a USB connection port, another data cable port, or adata cable connection via the electrical connection 218) that isaccessible on an external portion of the controller housing 210. Assuch, a cable may be connected to the control circuitry 240 to uploaddata or program settings to the controller circuit or to download datafrom the control circuitry 240. For example, historical data of bloodglucose level, blood glucose alarm limits (including notification alertlimits and safety alarm limits), medicine delivery (including basal andbolus deliveries), and/or TIL information can be downloaded from thecontrol circuitry 240 (via the cable connector) to a computer system ofa physician or a user for purposes of analysis and program adjustments.Optionally, the data cable may also provide recharging power.

Referring to FIGS. 9-10, the control circuitry 240 of the controllerdevice 200 may include a second power source 245 (FIG. 9) that canreceive electrical energy from a first power source 345 (FIG. 10) housedin the pump device 100. In this embodiment, the second power source 245is coupled to the power supply board 244 of the control circuitry 240.The hard-wired transmission of the electrical energy can occur throughthe previously described connectors 118 and 218. In such circumstances,the first power source 345 may include a high density battery that iscapable of providing a relatively large amount of electrical energy forits package size, while the second power source 245 may include a highcurrent-output battery that is capable discharging a brief current burstto power the drive system 300 of the pump device 100. Accordingly, thefirst battery 345 disposed in the pump device 100 can be used to deliverelectrical energy over time (e.g., “trickle charge”) to the secondbattery 245 when the controller device 200 is removably attached to thepump device 100. For example, the first battery 345 may comprise azinc-air cell battery. The zinc-air cell battery 345 may have a largevolumetric energy density compared to some other battery types. Also,the zinc-air cell battery may have a long storage life, especially inthose embodiments in which the battery is sealed (e.g., by a removableseal tab or the like) during storage and before activation.

The second battery 245 may include a high current-output device that ishoused inside the controller housing 210. The second battery 245 can becharged over a period of time by the first battery 345 and thenintermittently deliver bursts of high-current output to the drive system300 over a brief moment of time. For example, the second battery 245 maycomprise a lithium-polymer battery. The lithium-polymer battery 245disposed in the controller device 200 may have an initial current outputthat is greater than the zinc-air cell battery 345 disposed in the pumpdevice 100, but zinc-air cell battery 345 may have an energy densitythat is greater than the lithium-polymer battery 245. In addition, thelithium-polymer battery 245 is readily rechargeable, which permits thezinc-air battery 345 disposed in the pump device 100 to provideelectrical energy to the lithium-polymer battery 245 for purposes ofrecharging. In alternative embodiments, it should be understood that thesecond power source 245 may comprise a capacitor device capable of beingrecharged over time and intermittently discharging a current burst toactivate the drive system 105.

Accordingly, the infusion pump system 10 having two power sources 345and 245—one arranged in the pump device 100 and another arranged in thereusable controller device 200—permits a user to continually operate thecontroller device 200 without having to recharge a battery via an outletplug-in or other power cable. Because the controller device 200 can bereusable with a number of pump devices 100 (e.g., attach the new pumpdevice 100′ after the previous pump device 100 is expended anddisposed), the second power source 245 in the controller device can berecharged over a period of time each time a new pump device 100 isconnected thereto. Such a configuration can be advantageous in thoseembodiments in which the pump device 100 is configured to be adisposable, one-time-use device that attaches to a reusable controllerdevice 200. For example, in those embodiments, the “disposable” pumpdevices 100 recharge the second power source 245 in the “reusable”controller device 200, thereby reducing or possibly eliminating the needfor separate recharging of the controller device 200 via a power cordplugged into a wall outlet.

Referring now to FIG. 10, the pump device 100 in this embodimentincludes the drive system 300 that is controlled by the removablecontroller device 200 (see FIG. 2). Accordingly, the drive system 300can accurately and incrementally dispense fluid from the pump device 100in a controlled manner. The drive system 300 may include a flexiblepiston rod 370 that is incrementally advanced toward the medicinecartridge 120 so as to dispense the medicine from the pump device 100.At least a portion of the drive system 300 is mounted, in thisembodiment, to the pump housing 110. Some embodiments of the drivesystem 300 may include a battery powered actuator (e.g., reversiblemotor 320 or the like) that actuates a gear system 330 to reset aratchet mechanism (e.g., including a ratchet wheel and pawl), a springdevice (not shown) that provides the driving force to incrementallyadvance the ratchet mechanism, and a drive wheel 360 that is rotated bythe ratchet mechanism to advance the flexible piston rod 370 toward themedicine cartridge 120. Connected to piston rod 370 is a pusher disc 375for moving the plunger 125 of the medicine cartridge 120.

Some embodiments of the drive system 300 can include a pressure sensor380 disposed between the plunger engagement device 375 and the plunger125 for determining the pressure within the fluid path (e.g., inside themedicine cartridge 120, the infusion set 70, and the like). For example,the fluid pressure in the medicine cartridge 120 can act upon theplunger 125, which in turn can act upon the pressure sensor 380 arrangedon the dry side of the plunger 125. The pressure sensor 380 may comprisea pressure transducer that is electrically connected (via one or morewires) to a gateway circuit 318 so that the sensor signals can becommunicated to the controller device 200 (e.g., via the electricalconnectors 118 and 218). As such, data from the pressure sensor 380 canbe received by the controller device 200 for use with, for example, anocclusion detection module to determine if an occlusion exists in themedicine flow path. Alternatively, the controller device 200 may includean optical sensor system (not shown in FIGS. 9-10) to detect occlusionsin the fluid path. For example, a light emitter and light sensor mayeach be arranged on a sensor circuit in the controller device 200 (butaligned with the pump device 100) so that the light sensor can detectthe amount of light emitted by the light emitter and subsequentlyreflected from a component adjacent the fluid path. The reflected lightlevel detected may be used to determine the pressure within the fluidpath.

Referring now to FIG. 11, the infusion pump system 10 can be used todetermine a user's TIL at a particular point in time. For example, aprocess 400 for determining TIL information can be implemented by thecontroller device 200. As previously described, the pump assembly 60 canoperate to deliver insulin to the user by basal dosages, selected bolusdosages, or a combination thereof. A basal rate of insulin can bedelivered in an incremental manner (e.g., dispense 0.25 U every fifteenminutes for a rate of 1.0 Upper hour) to help maintain the user's bloodglucose level within a targeted range during normal activity when theuser is not eating or otherwise consuming food items. The user mayselect one or more bolus deliveries, for example, to offset the bloodglucose effects caused by the intake of food or to correct for anundesirably high blood glucose level. In some circumstances, the basalrate pattern may be programmed by a health care professional during aclinical visit (or, optionally, by the user) and may remain at asubstantially constant rate for a long period of time (e.g., a firstbasal dispensation rate for a period of hours in the morning, and asecond basal dispensation rate for a period of hours in the afternoonand evening). In contrast, the bolus dosages can be dispensed inuser-selected amounts based on calculations made by the controllerdevice 200. For example, the controller device 200 can be informed of ahigh glucose level (e.g., by user input, data received from the glucosemonitoring device 50, or the like) and can make a suggestion to the userto administer a bolus of insulin to correct for the high blood glucosereading. In another example, the user can request that the controllerdevice 200 calculate and suggest a bolus dosage based, at least in part,on a proposed meal that the user plans to consume.

The basal and bolus insulin dispensed into the user's system may actover a period of time to control the user's blood glucose level. Assuch, the user's body may include some amount of insulin that has notyet acted even while the infusion pump assembly 60 is activated todeliver additional dosages (basal, bolus, or both). In thesecircumstances, the controller device 200 may implement a process 400(FIG. 11) to determine the user's total insulin load (TIL), which canprovide an accurate indication of the previously dispensed insulin (bothbasal and bolus dosages) which has not yet acted in the user's body. TheTIL information can be determined in a manner that accounts for thesubstantial delay between the time that insulin is delivered to thetissue of the subcutaneous region and the time that this insulin reachesthe blood supply. For example, the delay between a subcutaneous deliveryof a bolus dosage of insulin and the peak plasma insulin level achievedfrom this bolus can be one hour or more. Additionally, the bolus dosagemay not enter the blood stream all at once. As such, the effect of thebolus can peak at about one to two hours and then decay in a predictablemanner over as much as eight hours or more (described in more detail inconnection with FIG. 12). Due to the time decay effects of insulinactivity, the user could be susceptible to request a subsequent bolusdosage while some insulin from a previously delivered bolus dosage hasnot yet acted upon the user (a scenario sometimes referred to as “bolusstacking”). To reduce the likelihood of undesirable bolus stacking, theTIL information can be determined by the controller device 200 on aperiodic basis so that the user can be aware of the previously dispensedinsulin which has not yet acted in the user's body. As described in moredetail below (in connection with FIGS. 17-21), the TIL information canalso be used to modify blood glucose alarm settings for the purpose ofincreasing sensitivity and/or decreasing false alarms.

For diabetics, their long term health may depend greatly on the abilityto accurately control their blood glucose levels under a wide variety ofconditions and to quickly and accurately predict and/or respond tochanges in blood glucose level from, for example, changes in activitylevel, carbohydrate ingestion, missed bolus dosages, missed meals, orthe like. As such, it can be beneficial for a user to employ theinfusion pump system 10 that enables the user to make well-informeddecisions about future insulin boluses and basal rates. For example, thecontroller device 200 can readily indicate to the user his or hercurrent TIL information, which is generally more accurate than otherinsulin estimation tools that are based on bolus dosages alone. Also,the controller device 200 can utilize insulin load information to modifyblood glucose alarm limits (including alert limits and safety alarmlimits), thereby increasing the utility of said alarms by increasingsensitivity under appropriate conditions, by decreasing the occurrenceof nuisance alarms, or both.

Referring in more detail to the illustrative process 400 shown in FIG.11, the process 400 for the determining of the TIL of a user can includea number of operations performed by the controller device 200. Inoperation 405, the controller device 200 can initiate a TIL calculationfor a particular time t_(n) based on, for example, a request by the user(on-demand calculation) or a controller routine that determines the TILinformation on a periodic basis (e.g., every 1 minute, every 2 minutes,every 5 minutes, every 10 minutes, every 30 minutes, or the like). Insome embodiments, the TIL value can be calculated based on two or(optionally) three components: a bolus insulin load component, a basalinsulin load component, and (optionally) a previous food component.

In operation 410, the controller device 200 can determine the bolusinsulin load at time t_(n) based on bolus dosages that have beendelivered to the patient in the recent past. In some embodiments, foreach bolus dosage dispensed within a predetermined period of time beforet_(n) (e.g., 6 hours, 7 hours, 7.5 hours, 8 hours, 10 hours, or thelike), the controller device 200 can estimate the amount of bolusinsulin that has not yet acted in the blood stream from time-decaymodels generated from pharmacodynamic data of the insulin. For example,a graph of an exemplary curve depicting the percent of insulin remainingversus time can be seen in FIG. 12. In particular, FIG. 12 illustratesan example of the insulin action curve generated from pharmacodynamicdata for the insulin stored in the cartridge 120. Thus, in thisembodiment, the bolus insulin load component of the TIL calculationrepresents the sum of all recent bolus insulin dosages wherein eachbolus insulin dosage is discounted by the active insulin function (whichmay be modeled on pharmacodynamic data as shown, for example, in FIG.12).

Still referring to FIG. 11, in operation 415, the controller device 200can determine the basal insulin load at time t_(n) based on, forexample, the previous basal rate during a predetermined period of time(e.g., 6 hours, 7 hours, 7.5 hours, 8 hours, 10 hours, or the like). Foreach basal insulin dispensation (e.g., 0.25 U dispensed every fifteenminutes, 0.5 U dispensed every fifteen minutes, 0.4 U dispensed everyten minutes, of the like), the controller device 200 can estimate theamount of basal insulin that has not yet acted in the blood stream fromtime-decay models generated from pharmacodynamic data of the insulin. Aspreviously described, FIG. 12 illustrates an example of the insulinaction curve generated from pharmacodynamic data for the insulin storedin the cartridge 120. Thus, in this embodiment, the basal insulin loadcomponent of the TIL calculation represents the sum of all recent basalinsulin dosages wherein each basal insulin dosage is discounted by theactive insulin function (which may be modeled on pharmacodynamic data asshown, for example, in FIG. 12). As described below in connection withFIG. 13, the basal insulin load at time t_(n) may approach a constantvalue if the basal dosage rate remains constant over an extended periodof time.

Optionally, the process 400 may include operation 420 in which theprevious food component is employed in the TIL calculation. Thecontroller device 200 can determine the previous food component basedon, for example, the total carbohydrates previously entered into thecontroller device 200 as being consumed by the user during apredetermined period of time before t_(n) (e.g., 6 hours, 7 hours, 7.5hours, 8 hours, 10 hours, or the like). The previous food component canbe determined, for example, by estimating the amount of carbohydratesthat have been consumed but not yet metabolized by the user's body so asto effect the blood glucose level. For each of the previous food itemsreported by the user, the controller device 200 can estimate thepreviously consumed food that has not yet been metabolized from atime-based model generated from a standard glycemic index.Alternatively, when the user enters information regarding food intake,the user can be prompted to identify the metabolization “speed” of thefood item based on the glycemic index for that food. In thesecircumstances, the user may be prompted to input the amount of food(e.g., grams of Carbohydrate or another representative value) and thenidentify the glycemic index (via a numerical scale or from a list of twoor more choices (e.g., “fast” metabolization and “slow” metabolization)to provide a more accurate time-based function for specific meals. Whenthis yet-to-be-metabolized carbohydrate value is estimated, it can betreated as a “negative” insulin component in the TIL calculation bymultiplying the yet-to-be-metabolized carbohydrate value by acarbohydrate ratio (e.g., 1 unit of insulin per 15 grams ofcarbohydrates). In some embodiments, the calculated value for theprevious food component can be displayed separately to the user (e.g.,to provide the user with information regarding the effects of thepreviously consumed carbohydrates).

Still referring to FIG. 11, in operation 425, the TIL at time t_(n) canbe calculated by summing the bolus insulin load, the basal insulin load,and (in some embodiments) the previously consumed food component, wherethe previous food component is treated as a negative insulin unit value.In these circumstances, the TIL values may accurately reflect both thepreviously dispensed insulin that has not yet acted (to reduce orotherwise effect the blood glucose level) and the previously consumedfood that has not yet been metabolized (to increase or otherwise effectthe blood glucose level). It should be understood from the descriptionherein that, in alternative embodiments, the process for determining theTIL information may not include the previous food component (asdescribed in connection with operation 420). In such embodiments, theTIL at time t_(n) can be calculated by summing both the bolus insulinload and the basal insulin load. Because this TIL determination is notbased merely on previous bolus deliveries, the TIL information mayaccurately reflect basal rate changes and the impact of stopping insulindelivery or changing basal delivery for a short period of time (e.g., atemporary basal rate change).

In operation 430, the TIL value can be stored in the memory of thecontroller device 200 (e.g., in the memory chip 248 or in another memorydevice coupled to the control circuitry 240). For example, thecalculated TIL value at time t_(n) can be stored in a database alongwith the time t_(n). The database may also store the current bloodglucose level at time t_(n), which may be generated from the sensorsignal received from the monitoring device 50 (FIG. 1). As described inmore detail below, the database can maintain a historical record of theTIL information, the time information, and (optionally) the detectedblood glucose information that is accessible by the controller device200 or by an external computer.

In operation 435, the TIL information can be displayed on the userinterface 220 of the pump controller device 200. The TIL information canbe retrieved from the memory device that stores the recently calculatedTIL value. In particular embodiments, the display 222 of the userinterface 220 may be configured to display an alarm information screenin response to an abnormal condition (e.g., a high blood glucose level).In the example depicted in FIG. 1, the display 222 can indicate an alert(a low insulin load in this example), the recently determined TILinformation (0.5 U insulin load in this example), the user's currentblood glucose level (180 mg/dl in this example), an indication ofwhether the user's blood glucose level is rising or falling (the upwardfacing arrow indicates an increasing glucose level in this example), andan indication that one or more glucose alarm limits have been modified(one or more alarm limits have been decreased in this example). Inanother example, as shown in FIG. 2, the display 222 of the userinterface 220 provides an alarm information screen that indicates analert (high insulin load in this example), the recently calculated TILinformation (a 4.2 U load in this example), the user's blood glucoselevel (99 mg/dl in this example), an indication of whether the user'sblood glucose level is rising or falling (the downward facing arrowindicates a falling glucose level in this example), and an indicationthat one or more glucose alarm limits have been modified (one or morealarm limits have been increased in this example).

In operation 440, the process 400 can return to initiate a new TILcalculation after a period of time. For example, the operation 440 cancause the controller device 200 to calculate the TIL for time t_(n+1) byreturning to operation 405. As previously described, the controllerdevice 200 can initiate the subsequent TIL calculation for thesubsequent time t_(n+1) based on a request from the user or based on aprogram that causes calculation of the TIL information on a periodicbasis (e.g., every 1 minute, every 2 minutes, every 5 minutes, every 10minutes, every 30 minutes, or the like). The subsequent TIL value fortime t_(n+1) can be stored in the memory of the controller device 200(e.g., in the previously described database) and can be displayed on theuser interface 220 of the controller device 200.

Referring now to FIG. 12, in some embodiments, the controller device 200can calculate the TIL information using, at least in part, time-basedmodels derived from pharmacodynamic data. As previously described, theTIL value of a user can include a bolus insulin load component and abasal insulin load component, each of which may be determined using atime-decay model generated from pharmacodynamic data associated with theinsulin stored in the cartridge 120. As shown by way of example in FIG.12, the controller device 200 can utilize a time-decay curve(represented by curve 450), which is generated from pharmacodynamicdata, to estimate the percentage of insulin remaining in a user's bodyafter a particular period of time.

Referring now to FIG. 13, graph 500 is an exemplary depiction of how aconstant basal delivery can affect a user's TIL information. In thisexample, the basal insulin deliveries are represented as a series ofbasal infusion points 506 (e.g., dosages of 0.25 U every fifteen minutesto provide a basal rate of 1.0 U per hour). It should be understood fromthe description herein that, while the basal rate is sometimes describedas a generally continuous administration, it can be implemented a seriesof small injections given at regular intervals. Because the basal rateis constant over a period of seven hours with no bolus dosages, theinsulin delivery pattern 505 is represented as a horizontal, straightline that depicts a constant basal rate of 1.0 units/hour. For thepurposes of this example, it is presumed that there were no basal orbolus insulin deliveries prior to time=0 (hours), there were nopreviously consumed carbohydrates acting on the user's total insulinload, and that the user's TIL (represented by TIL curve 510) was also0.0 prior to time=0. This may occur, for example, after the user wakesin the morning and then activates the pump assembly 60 to deliver thebasal insulin. As such, the user's TIL value has only a single component(basal insulin load) and is equal to zero before time=0. The othercomponents of the TIL calculation, such as the bolus insulin load andthe previous food component, are zero in this example. At time=0 thefirst basal infusion (represented by point 507) of 0.25 units is made.Since substantially none of the insulin delivered in the first infusion(point 507) has acted on the user at time=0, the entire contents of theinfusion (0.25 units) are now part of the TIL, which is reflected in theTIL curve 510. With the subsequent boluses 508 and 509, the TILincreases, while some small portion of the previously dispensed insulinacts in the blood stream. This is estimated from a time-decay curve(refer, for example, to FIG. 12), which is generated frompharmacodynamic data. As time increases, however, the amount of insulinleaving the insulin load and entering the blood stream increases untilpoint 512 where the amount of insulin leaving the insulin load to act inthe blood stream is substantially equal to the amount of insulinentering the insulin load due to the constant basal infusion. If thebasal rate remains constant, than the TIL will continue to remain at theequilibrium value shown on the graph 500. In this example, the TILreaches equilibrium at a value of about 2.25 U (as shown on theleft-side axis in graph 500).

In some circumstances, the TIL information can be stored, displayed, orboth as a normalized value (e.g., the TIL % value indicated on theright-side axis of the graph 500). Although the TIL value (in units ofinsulin) is a useful number, that actual value can vary from user touser depending on his or her insulin intake characteristics. The TIL %value can be used as one feature to normalize the TIL calculation forconvenient analysis or comparison between users. For example, the TIL %value can be calculated as follows:TIL % value=[(Actual TIL)−(theoretical TIL_(basal))]/(theoreticalTIL_(basal))×100,

-   -   where theoretical TIL_(basal) represents the TIL that would have        been generated based only on the user's basal insulin dosages        (e.g., presuming no bolus insulin and no previous food        components)        As such, in the example depicted in FIG. 13, the TIL % value        remains at a constant of 0% (refer to TIL % curve 515) because        the actual TIL value remains equal to the theoretical        TIL_(basal) value (based only on the user's basal insulin        dosages). However, when the user receives bolus dosages and/or        or has a previous food component (such circumstances are        described in more detail below), the TIL % value may provide for        prompt analysis of the user's insulin status and provide for        easy comparison between users.

The controller device 200 can display the TIL information on the userinterface 220 as the TIL value (in units of insulin as shown, forexample, in FIG. 1), as the TIL % value (normalized to be a percentageas shown, for example, in FIG. 2), or as both the TIL value and the TIL% value. Moreover, the TIL information can be stored in a memory device(e.g., memory device 248) of the controller device 200 as the TIL value(in units of insulin), as the TIL % value (normalized to be apercentage), or as both the TIL value and the TIL % value.

Referring now to FIG. 14, the controller device 200 can calculate theTIL information based, at least in part, on both basal insulindispensations and bolus insulin dispensations. In this example, graph600 includes an insulin delivery curve 610 made up of individual basaldispensations 612 and bolus dispensations 614, 616, and 618, a TIL curve620 (which accounts for both a basal load component and a bolus loadcomponent), and a TIL % curve 630. In region 640, the basal infusionrate remains constant and no boluses are infused, so the TIL curve 620remains at it's equilibrium value while the TIL % curve 630 remains at0% (similar to the characteristics described in connection with FIG.13). At about time=8 hours, a bolus delivery 614 of about 5 insulinunits is delivered to the user. This bolus dosage may be selected inresponse to the user proposing new food intake, the user attempting tooffset an elevated blood glucose level that requires correction, or thelike. This bolus delivery 614 raises the user's TIL value to slightlyhigher than 7 units, or about 5 units plus the equilibrium value. Inregion 650, the user's TIL value decays or otherwise decreases as thepreviously dispensed insulin transitions to act in the user's bloodstream (e.g., to lower or otherwise affect the user's blood glucoselevel). With the subsequent boluses 616 and 618, at about time=10 andtime=12 hours respectively, the user's TIL value increases with eachbolus, and thereafter decays.

As shown in FIG. 14, the TIL % value is also affected by the bolusdeliveries 614, 616, and 618. For example, the TIL % curve 630 indicatesthat the TIL % value increases from 0% to about 222% immediately afterthe first bolus delivery 614. Although the TIL value (in units ofinsulin, represented in curve 620) is a useful number, that value mayvary from user to user depending on his or her insulin intakecharacteristics (e.g., type of insulin, insulin sensitivity,carbohydrate ratio, overall insulin requirements, or the like). Here,the TIL % value of about 222% represents a normalized value forconvenient analysis by the user or a health care provider. Inparticular, this normalized value indicates to the user that the TIL ismore than two times (e.g., 222%) what it would ordinarily be if the userhad maintained just the constant basal rate (from region 640) withoutany bolus delivery 614). In region 650, the user's TIL % value decays orotherwise decreases as the previously dispensed insulin transitions toact in the user's blood stream (e.g., to lower or otherwise affect theuser's blood glucose level). With the subsequent boluses 616 and 618, atabout time=10 and time=12 hours respectively, the user's TIL % valueincreases with each bolus, and thereafter decays.

Referring now to FIG. 15, as previously described, the TIL informationcan be determined in a manner that accounts for both the bolusdeliveries and the basal deliveries (not merely previous bolusdeliveries). As such, the TIL values may accurately reflect basal ratechanges and the impact of stopping insulin delivery (e.g., duringperiods in which insulin delivery is stopped or basal delivery isaltered, during activities such as swimming or another exercise, etc.).The insulin delivery pattern in FIG. 15 is similar to the previouslydescribed scenario shown in FIG. 14, except that the basal delivery isstopped between time=5 hours and time=7 hours (refer to the basaldelivery curve 710 in graph 700). For example, the graph 700 includes aregion 740, in which the basal infusion rate remains constant and noboluses are infused, so the TIL curve 720 approaches a constant valuewhile the TIL % curve 730 remains at 0% (similar to the previouslydescribed scenario shown in FIG. 14). At about time=5 hours, basaldelivery is suspended for a period of approximately two hours (refer toregion 750). As a result, the TIL curve 720 decays or otherwise reducesin that period of time because the previously dispensed insulintransitions to act in the user's blood stream (e.g., to lower orotherwise affect the user's blood glucose level) and no further insulinis being dispensed during that time period. Also, in the exampledepicted in FIG. 15, the TIL % curve 730 transitions into negativevalues (e.g., −25%, −50%, etc.) because the insulin dosages were ceasedbetween time=5 hours and time=7 hours. During such periods of ceasedinsulin delivery, the actual TIL value may become less than theoreticalTIL_(basal) (e.g., the TIL that would have been generated based on theuser's basal insulin dosages), which causes the TIL % values totransition into negative values. In one example, the user may readilyrecognize that his or her insulin load (e.g., TIL %=−25%) isapproximately ¼th less than what it normally would have been if he orshe had maintained the scheduled basal insulin delivery rate.Accordingly, the TIL values and the TIL % values can accurately reflectbasal rate changes and the impact of stopping insulin delivery.

As shown in FIG. 15, the basal insulin rate restarts at about time=7hours, which causes the TIL value to increase and the TIL % value toreturn toward 0%. In this example, a bolus delivery 714 of about 5 unitsis delivered to the user at about time=8 hours, thereby raising theuser's TIL value about 5 units to slightly higher than 6 units. Such abolus delivery 714 also causes the TIL % value to increase to slightlyless than 200% in this example. This normalized value indicates to theuser that the TIL is slightly less than two times what it wouldordinarily be if the user had maintained just the constant basal rate(from region 740) without any bolus delivery 714. In region 760, theuser's TIL value and the TIL % value decays or otherwise decreases asthe previously dispensed insulin transitions to act in the user's bloodstream (e.g., to lower or otherwise affect the user's blood glucoselevel). With subsequent bolus deliveries 716 and 718 at about time=10and time=12 hours respectively, the user's TIL value and the TIL % valueincreases with each bolus, and thereafter decays.

Referring now to FIG. 16A, the TIL value may return to a constant value(and the TIL % value may return to 0%) after an extended period of timewith no bolus activity. For example, the graph 800 in FIG. 16A issimilar to the previously described graph in FIG. 15, except that itshows the insulin delivery pattern over a greater duration of time. Insome embodiments, a user may continue to receive insulin deliveries fromthe pump assembly 60 during his or her period of sleep. The user canreceive only his or her ordinary basal dosages during this period ofsleep so as to maintain his or her blood glucose level within a saferange. In the example depicted in FIG. 16A, the user receives a bolusdelivery 819 before a dinner meal at about time=18 hours. Thereafter, nofurther bolus dosages are provided for the remainder of the day, and theuser receives only the ordinary basal rate delivery (refer to region 870in FIG. 16A). During this extended period of receiving only the basaldeliveries as shown in region 870, the TIL values (refer to TIL curve820) decay or otherwise decrease from a value greater than 10 units ofinsulin to a constant value of slightly greater than 2 units. Also,during this extended period in region 870, the TIL % values (refer toTIL % curve 830) decay or otherwise decrease from a normalized value ofalmost 400% to the constant value of 0%. Accordingly, over a period of aday or more, the TIL value and the TIL % value can “reset” or otherwisereturn to a constant value during periods of sleep (when the userreceives nighttime basal dosages) or during other extended periodsduring which no bolus activity occurs.

In the previous examples, described in connection with FIGS. 14-16A, thecontroller device 200 calculated the TIL at any given time by summingthe insulin load due to basal delivery and the insulin load due to oneor more bolus deliveries (if any). These examples depict embodiments ofthe controller device 200 that provide the advantage of using moreaccurate insulin action curves to estimate the amount of insulin thathas been delivered to a user (but not yet acted in that user's bloodstream), and the advantage of including a basal insulin load componentto the TIL calculation (thus incorporating all delivered insulin in theTIL calculation). As described previously, a calculated TIL value can beused to, for example, predict future blood glucose levels and/or can beused in the calculation of suggested bolus amounts. As such, thecontroller device 200 can employ the TIL information to provide accurateinformation to the user and to avoid “bolus stacking” and unsafe swingsin blood glucose level.

In much the same way that insulin does not immediately enter the bloodstream and act upon a user after subcutaneous delivery, ingestedcarbohydrates can also take time to fully act upon the user's bloodglucose level. In some embodiments, the controller device 200 can alsoinclude a component in the TIL calculation that takes into account foodwhich has been previously consumed but not yet acted in the user.

Referring now to FIG. 16B, as previously described, the TIL informationcan account for the user's previously consumed food in addition to thebolus deliveries and the basal deliveries. In these circumstances, theTIL values may accurately reflect both the previously dispensed insulinthat has not yet acted and the previously consumed food that has not yetbeen metabolized. The insulin delivery pattern in FIG. 16B is similar tothe previously described scenario shown in FIG. 16A, except that theuser in FIG. 16B skips a bolus delivery at time=12 hours (note that FIG.16A shows a bolus delivery 816 at time=12 hours). Also, in the exampledepicted in FIG. 16, the TIL calculation process also accounts forpreviously consumed food (e.g., the previous food component). Forexample, the graph 900 in FIG. 16B includes a basal delivery curve 910made up of individual basal infusions 912, a TIL curve 920, and a TIL %curve 930. At about time=12 hours, the user enters meal data into thecontroller device 200, but no bolus delivery is dispensed (e.g., due touser error or another reason), leading to an immediate drop in the TILcurve 920 and the TIL % curve 930. This substantial decrease in the TILvalue and the TIL % value is due to the fact that the process forcalculating the TIL information accounts for the user's previouslyconsumed food intake (in addition to the bolus deliveries and the basaldeliveries). Thus, the controller device 200 receives information attime=12 hours that the user has consumed food but no bolus delivery wasprovided (e.g., a missed bolus situation). As such, the previous foodcomponent of the TIL calculation becomes much more significant than thebolus load component and the basal load component (thereby driving theTIL value and the TIL % value into the negative value range). In someembodiments, this drop of the TIL curve 920 into the negative regioncould result in the controller device 200 alerting the user to apotentially unsafe condition (e.g., a pending significant rise in bloodglucose level) long before the user's blood glucose level begins to riseoutside of a targeted range. Such a safety feature can provide enhancedprotection for the user, who would have the opportunity to select acorrection bolus before the blood glucose level increased to unsafeconditions.

Still referring to FIG. 16B, at about time=18 hours, a bolus delivery915 is provided to the user, but no meal data is entered into thecontroller device 200. Unlike the previous situation at time=12 hours inwhich the user missed a bolus dosage, this situation arises at time=18hours when the user misses a meal. This situation may occur, forexample, where the user schedules a bolus dosage in anticipation of afuture meal, but then forgets or fails to consume the proposed meal.Such conditions can lead to a sharp increase in the TIL curve 920 andthe TIL % curve 930. As such, the bolus load component of the TILcalculation becomes much more significant than the previous foodcomponent (thereby driving the TIL value and the TIL % value upward intothe higher value range). In some embodiments, this sharp increase of theTIL curve 920 could result in the controller device 200 alerting theuser to a potentially unsafe condition (e.g., a pending significant dropin blood glucose level) long before the user's blood glucose levelbegins to fall outside of a targeted range. Such a safety feature canprovide enhanced protection for the user, who would have the opportunityto consume food items and enter the food data in the controller device300 before the glucose level decreased to unsafe conditions. If the userdid consume food at about time=18 hours but merely forgot to enter theinformation into the controller device 200, the user would have theopportunity to enter the meal information, thus causing the next TILcalculation to be corrected. For example, in response to the alert fromthe controller device 200, the controller device may prompt the user toenter the previous food information (if he or she forgot to enter themeal information) or to start the consumption of food items.

Similar to embodiments previously described in connection with FIG. 16A,the TIL value may return to a constant value (and the TIL % value mayreturn to 0%) after an extended period of time with no bolus activityand no food consumption activity. In this example shown in FIG. 16B,during the period between time=18 hours and time=24 hours, the user maycease bolus activity and food consumption (e.g., as he or she preparesfor sleep and begins to sleep overnight). During this extended period ofreceiving only the basal deliveries as shown in region 970, the TILvalues (refer to TIL curve 920) decay or otherwise decrease to aconstant value of slightly greater than 2 units. Also, during thisextended period in region 970, the TIL % value (refer to TIL % curve930) decay or otherwise decrease to a constant value of 0%.

In some embodiments, the controller device 200 can use data indicativeof the user's blood glucose level (e.g., information received from themonitoring device 50, user input, glucose test strips inserted into thecontroller device 200, or the like) to alert the user of potentiallyunsafe glucose levels. For example, in response to a user's recent bloodglucose data that is indicative of a high blood glucose level, thecontroller device 200 may alert the user to the high blood glucoselevel, request input from the user, suggest a bolus dosage, or anycombination thereof. Alternatively, In response to data indicative of alow blood glucose level, the controller device 200 may alert the user,request input from the user, suggest a meal to be consumed, or anycombination thereof. In some embodiments, a fixed high and low glucosealarm limits can be preset (e.g., by a health care provider) andcompared to the user's blood glucose level to determine if the currentblood glucose level is outside of a normal range. In other embodiments,the parameters defining a normal range can be dynamically adjusted tobenefit the user, using data such as the user's current insulin load.

In some embodiments, after receiving a bolus dosage of insulin (e.g., inresponse to a high blood glucose level), there can be a delay betweenthe time that a user receives the bolus dosage and the time that asubstantial portion of that bolus acts on the user. During this timeperiod, the user's blood glucose level can remain high, or continue toincrease. Similarly, after consuming a meal (e.g., in response to a lowblood glucose level), there can be a delay between the time that theuser consumes food and food is able to act on the user (e.g., raise theuser's blood glucose level). Due in part to these delays, in can be canbe beneficial for a user to employ an infusion pump system that canidentify information indicative of future unsafe blood glucose levelsand can suggest corrective actions (e.g., receive a bolus dosage,consume carbohydrates, or the like) based on this information, therebyminimizing, or eliminating, the amount of time that a user experiencesunsafe or undesirable blood glucose levels. The previously describeddelays in insulin and food action can also cause a user to be alerted toa condition (e.g., high blood glucose level, low blood glucose level, orthe like) that has been previously corrected for (e.g., by the userreceiving a bolus, the user consuming carbohydrates, or the like), butwhere the corrective action has not yet acted on the user. For example,if a user consumes a high carbohydrate meal and waits for a period oftime (e.g., 45 minutes) before receiving a bolus, the carbohydratescould later have the affect of raising the blood glucose level of theuser before the insulin takes affect. In examples such as this, theuser's blood glucose level can temporarily rise above an upper bloodglucose alarm limit and later, without additional correction, fall belowthat upper alarm limit into a normal range, when the insulin load (e.g.,the previously received bolus) acts on the user. In some embodiments,giving an alarm given when the blood glucose level rises above an upperglucose limit, but subsequently falls below this limit withoutcorrective action, may be considered as a nuisance alarm by the user. Insome circumstances, it can be beneficial for the user to employ aninfusion pump system that can identify information indicative ofnuisance alarms and use this information to modify alarm parameters(e.g., upper and lower alarm limits) to lower the likelihood, oreliminate the occurrence, of these nuisance alarms.

Referring now to FIG. 17, the infusion pump system 10 can be configuredto determine the user's insulin load (e.g., an estimated amount ofinsulin already delivered to the user's body), and thereafter adjust thealarm limit parameter in response to the user's insulin load.Accordingly, the glucose alarm limit parameters may be dynamicallymodified over time as the user's insulin load increases or decreases. Insome embodiments, the controller device 200 can be used to dynamicallymodify parameters associated with a user's blood glucose alarm range(e.g., modify the upper alarm limit, modify the lower alarm limit, orboth) based at least in part, on the user's insulin load. For example, aprocess 1000 for dynamically modifying glucose alarm parameters, basedat least in part on the user's insulin load, can be implemented by thecontroller device 200. As previously described, the controller device200 can receive data indicative of blood glucose information from, forexample, the glucose monitoring device 50. The controller device 200 cancompare the data and/or the information derived from the data to upperand lower glucose alarm limits for the purpose of determining if theuser's blood glucose level is outside of a normal range. In particularembodiments, the default upper and lower glucose alarm limits may beprogrammed by a health care professional during a clinical visit (or,optionally, by the user) and may remain at these programmed values for along period of time (e.g., until the next clinical visit, until the usergets a new controller device 200, or the like). In some circumstances,it may be beneficial to the user for the controller device 200 todynamically change glucose alarm parameters by, for example, calculatingmodified upper and/or lower glucose alarm limits and subsequentlycomparing the user's current blood glucose level to the modified limits.

Referring in more detail to the illustrative process 1000 shown in FIG.17, the process 1000 for calculating modified upper and lower glucosealarm limits and determining if a user's blood glucose level is outsideof a modified normal range (e.g., has risen above the modified upperglucose alarm limit, fallen below the modified lower glucose alarmlimit, or the like) can include a number of operations performed by thecontroller device 200. In operation 1005, the controller device 200 canreceive data indicative of a user's blood glucose level. For example,the controller device 200 can receive data, via wired or wirelesscommunication, from the glucose monitoring device 50. In other examples,the controller device 200 can access previously stored blood glucosedata from memory (such as the memory chip 248). In still other examples,a user can insert a glucose testing strip into a strip reader portion ofthe pump assembly 60, or enter information directly into the userinterface 220.

In operation 1010, the controller device 200 can generate dataindicative of the user's insulin load. As described previously, thephrase “insulin load” can include an estimate previously dispensedinsulin, such as a sum of recent bolus activity, and may preferablyinclude an estimated value of previously dispensed insulin that has notyet acted in the user's body, such as total insulin load (TIL)information (a more comprehensive determination as described in moredetail below), traditional insulin-on-board estimates (which typicallyaccount for only bolus dosages), or other such estimated insulin loadvalues. For example, as described previously in connection with FIG. 11,the controller device 200 can calculate the user's TIL value or theuser's insulin-on-board estimate to generate the insulin load data. Itshould be understood that this type of insulin load data can begenerated when it is retrieved from memory (e.g., the memory chip 248).In another example, the insulin load data may be indicative of the sumof the recent bolus activity (e.g., all bolus dosages within the recentone hour, two hours, or the like), and the controller device 200 canretrieve the recent bolus dosage values from the memory chip 248. Theinsulin load data generated in operation 1010 can be used by thecontroller device 200 in operation 1015 to modify the default upper andlower glucose alarm limits, which may be set by a health careprofessional during a clinic visit, by the user, or a combinationthereof. Exemplary processes used to modify the default alarm limits aredescribed in more detail in connection with FIGS. 18-21. In one example,the controller device 200 can determine if the user's insulin load iswithin a normal range. If so, the controller device 200 can leave thealarm limits unmodified or return modified values that are identical tothe preset values. If the user's insulin load is outside of the normalrange, the controller device 200 can modify one or more of the glucosealarm limits by, for example, multiplying them by a scaling factor thatcan be based, at least in part, on the value of the user's insulin load(described in more detail in connection with FIGS. 20-21). In anotherexample, if the user's insulin load is outside of the normal range, thecontroller device 200 can modify one or more of the glucose alarm limitsby a predetermined function such as step function in which the alarmlimits are increased or decreased by a preset value (e.g., increase ordecrease the upper and lower alarm limits by 50 mg/dL). In furtherexamples, the controller device 200 can modify the glucose alarm limitsusing one or more equations that include insulin load values (e.g., theuser's TIL value, the user's TIL % value, the user's IOB value, the sumof the recent bolus activity, or the like). Exemplary processes tomodify the alarm limits using equations that include insulin load valuesare described in connection with FIGS. 18-19.

Some embodiments may include operation 1016, in which the controllermodifies the alarm timer in response to the user's insulin load. Forexample, the high blood glucose alarm may include a timer that causesthe alarm to be repeated to the user at a timer interval (e.g., every 30seconds, every minute, every two minutes, every five minutes, or thelike). Thus, the user may be provided with the option to “snooze” thehigh blood glucose alarm while he or she is taking actions to resolvethe alarm circumstances. This “snooze” timer can be modified to reducethe occurrences of repeated nuisance alarms or to increase theoccurrence of serious safety alarms. In one example, the controllerdevice 200 can determine if the user's insulin load is within a normalrange. If so, the controller device 200 can leave the alarm timerunmodified or return modified values that are identical to the presetvalues. If the user's insulin load is outside of the normal range, thecontroller 200 can modify the alarm timer, for example, by multiplyingthe default timer value by a scaling factor (e.g., reducing the timervalue by half, by increasing the timer value by two, or the like). Forinstance, in circumstances in the controller device receives informationindicative of a high blood glucose value but also determines that theinsulin load is also a high value (e.g., the user recently received abolus), the controller 200 can modify the alarm timer by increasing thedefault timer value by two (e.g., from two minutes to four minutes). Assuch, the controller device 200 may alert the user that the bloodglucose level is high, but then the controller device 200 may delayrepeating that alarm to reduce nuisance alarms as the insulin begins toact in the user's body. It should be understood that this operation 1016may be performed in addition to operation 1015 or as an alternative tooperation 1016. Thus, in some embodiments, the controller device canmodify the glucose alarm limits in response to the user's insulin load(operation 1015), modify the alarm timer in response to the user'sinsulin load (operation 1016), or modify both the glucose alarm limitsand the alarm timer (operations 1015 and 1016).

Referring to operation 1020 in FIG. 17, in some embodiments, it may behelpful to the user for the controller device 200 to alert the user thatthe glucose alarm limits have been modified. Exemplary alerts aredepicted on the display 222 of the controller 200 in FIGS. 1 and 2. Inoperation 1020, the controller device 200 can optionally alert the userthat the glucose alarm limits have been modified. In one example, thecontroller device 200 may notify the user whenever a glucose alarm limitis modified. In another example, the controller device 200 may onlynotify the user that a glucose alarm limit has been modified when a highor low glucose alarm is communicated to the user. In still anotherexample, the controller device 200 may notify the user that a glucosealarm limit has been modified only when the modification meets certaincriteria (e.g., the glucose alarm limit has been modified by more than10 percent, more then 15%, more than 10 units, or the like).

In operation 1025, the controller device 200 can compare the user'scurrent (or most recent) blood glucose level (e.g., received inoperation 1005) to the modified upper glucose alarm limit (e.g.,determined in operation 1015). If the user's blood glucose level isgreater than the modified upper glucose alarm limit, the controllerdevice 200 can perform operation 1030 and communicate to the user a highblood glucose alarm (e.g., an audible alarm or alert, text on a display222 describing an alarm or alert, a vibratory alarm or alert, anothercommunicative output, or a combination thereof). In operation 1035, thecontroller device 200 can prompt the user to take action to correct thehigh blood glucose level. In one example, the controller device 200 (viauser interface 220) can suggest a bolus dosage based, at least in part,on the user's insulin load and can prompt the user to accept, modify, ordecline the suggestion. The controller device 200 can prompt the user toenter information about a meal that the user may have consumed, butforgot to enter into the user interface 220. In another example, thecontroller device 200 can use a cellular phone network to call anemergency contact number programmed in the controller 200. Aftercompletion of operation 1035, the process 1000 can return to operation1005 where the controller device 200 can receive additional informationindicative of the user's blood glucose level.

If, in operation 1025, the controller 200 determines that the user'sblood glucose level is not greater than the modified upper glucose alarmlimit determined in operation 1015, the controller device 200 canperform operation 1040 to compare the user's blood glucose level to themodified lower glucose alarm limit obtained in operation 1015. Duringthis operation 1040, if the controller 200 determines that the user'sblood glucose level is less than the modified lower glucose alarm, thecontroller 200 can perform 1045 and communicate to the user a low bloodglucose alarm (e.g., an audible alarm or alert, text on a display 222describing an alarm or alert, a vibratory alarm or alert, anothercommunicative output, or a combination thereof).

Still referring to FIG. 17, in operation 1050, the controller device 200can prompt the user to take action to correct the low blood glucoselevel. In one example, the controller device 200 can suggest that theuser consume some food. In another example, the controller 200 cansuggest an amount (e.g., in carbohydrates) and type of food to consume.After completion of operation 1050, the process 1000 can return tooperation 1005 where the controller device 200 can receive additionalinformation indicative of the user's blood glucose level.

If, in operation 1040, the controller 200 determines that the user'sblood glucose level is not less than the modified lower glucose alarmlimit determined in operation 1015, this indicates that the user'sglucose level is within the normal range (with the modified limits asdescribed in operation 1015). As such, there may be no need tocommunicate a blood glucose alarm to the user. Rather, the process 1000can return to operation 1005 where the controller device 200 willstandby to receive subsequent information indicative of the user's bloodglucose level.

In some embodiments, as described previously, a user can benefit fromdynamically changing glucose alarm parameters to, for example, increasethe sensitivity of particular glucose alarms, decreasing the likelihoodand/or number of nuisance glucose alarms, or the like. The controllerdevice 200 can, in response to a user's insulin load (e.g., TIL values,TIL % value, IOB, or the like), increase the sensitivity of glucosealarms and/or decrease the number of nuisance glucose alarms bymodifying the upper and/or lower glucose alarm limits. A user's bloodglucose level can then be compared to the modified glucose alarm limitsto determine whether a low or high glucose alarm should be communicatedto the user.

Referring now to FIG. 18, the upper and lower glucose alarm limitsassociated with a user and stored in the controller 200 can be modifiedin response to the user's TIL value. As previously described inconnection with FIG. 11, the controller device 200 can estimate a user'sinsulin load by calculating the user's TIL value from, for example, auser's recent basal deliveries, recent bolus dosages, and recentcarbohydrate intake. This TIL value, along with additional information,such as the time the TIL value was calculated, can be stored in thememory (e.g., the memory chip 248) of the controller device 200 to beused later, for example, in modifying the user's glucose alarm limits.For example, as shown in FIG. 18, a process 1100 for modifying the upperand lower glucose alarm limits associated with a user, in response tothe user's TIL value, can be implemented by the controller device 200.In operation 1105, the controller device 200 can retrieve a user'srecent TIL value from memory. In some embodiments, instead of retrievinga recent TIL value from memory, the controller device 200 can initiatethe calculation of a current TIL value and utilize this value insubsequent operations. Also, as previously described, the user can havea theoretical basal TIL value that is calculated, for example, when theuser is receiving a constant basal rate, no bolus dosages, and is notconsuming carbohydrates. In some embodiments, the user can have morethan one basal rate, each with a corresponding theoretical basal TILvalue. When calculated, the one or more basal TIL values can be storedin memory. In operation 1110, one or more of the user's theoreticalbasal TIL values can be retrieved by the controller device 200. Aspreviously described, the controller device 200 can include upper andlower glucose alarm limits (e.g., that define a normal blood glucoserange) that were previously programmed and stored in the memory of thecontroller device 200. In operation 1115, the controller device 200 canretrieve an upper glucose alarm limit from memory.

In some embodiments, if a user's insulin load is lower than normal, thelikelihood of the user's blood glucose level rising is higher. In thesecircumstances, the controller device 200 can provide enhanced usersafety by reducing the high glucose alarm limit, which can alert theuser to a potentially dangerous increase in blood glucose level soonerthan if the high glucose alarm limit was not modified. Alternatively,when the user's insulin load value is higher than normal, the likelihoodof the user's blood glucose level rising is lower. In thesecircumstances, the controller device 200 may reduce the likelihood ofnuisance alarms by raising the high glucose alarm limit, which canprovide additional convenience to the user.

For example, in operation 1120, the controller device 200 can use theTIL value obtained during operation 1105, the theoretical basal TILvalue obtained during operation 1110, and the upper glucose alarm limitobtained during operation 1115 to calculate a modified upper glucosealarm limit to increase the sensitivity of the high glucose alarm ordecrease the number of nuisance high glucose alarms. For example, themodified upper glucose alarm limit can be calculated as follows:Modified Upper Glucose Alarm Limit=Upper Glucose Alarm Limit+[ScalingFactor_(Upper)×(TIL_(current)−TIL_(basal))/insulin sensitivity], basal,

-   -   where TIL_(basal) represents the theoretical TIL that would have        been generated based only on the user's basal insulin dosages        (e.g., presuming no bolus insulin and no previous food        components), Scaling Factor_(Upper) represents a scaling factor        (e.g., stored in the controller device 200) that can be used to        correlate changes in the user's TIL values to changes in the        user's upper glucose alarm limit, and the insulin sensitivity        represents a preset parameter that correlates insulin received        by a user to the resulting affect on that user's blood glucose        level.

In operation 1125, the modified upper glucose alarm limit can be storedin the memory of the controller device 200, to be accessed later, forexample, by the controller device 200 and compared to a user's currentblood glucose level.

Still referring to FIG. 18, in some embodiments, if a user's insulinload is higher than normal, the likelihood of the user's blood glucoselevel falling is higher. In these circumstances, the controller device200 may provide enhanced user safety by increasing the low glucose alarmlimit, which can alert the user to a potentially dangerous decrease inblood glucose level sooner than if the low glucose alarm limit was notmodified. Alternatively, when the user's insulin load value is lowerthan normal, the likelihood of the user's blood glucose level falling islower. In these circumstances, the controller device 200 may reduce thelikelihood of nuisance alarms by lowering the low glucose alarm limit,which can provide additional convenience to the user.

For example, in operation 1130, the controller device 200 can retrieve alower glucose alarm limit from memory. In operation 1135, the controllerdevice 200 can use the TIL value obtained during operation 1105, thebasal TIL value obtained during operation 1110, and the lower glucosealarm limit obtained during operation 1130 to calculate a modified lowerglucose alarm limit to increase the sensitivity of the low glucose alarmor decrease the likelihood and/or number of nuisance low glucose alarms.For example, the modified lower glucose alarm limit can be calculated asfollows:Modified Lower Glucose Alarm Limit=Lower Glucose Alarm Limit+[ScalingFactor_(Lower)×(TIL_(current)−TIL_(basal))/insulin sensitivity]

-   -   where TIL_(basal) represents the theoretical TIL that would have        been generated based only on the user's basal insulin dosages        (e.g., presuming no bolus insulin and no previous food        components), Scaling Factor_(Lower) represents a scaling factor,        stored in the controller device 200, that can be used to        correlate changes in the user's TIL values to changes in the        user's lower glucose alarm limit, and the insulin sensitivity        represents a preset parameter that correlates insulin received        by a user to the resulting affect on that user's blood glucose        level.

In operation 1140, the modified lower glucose alarm limit can be storedin the memory of the controller device 200, to be accessed later, forexample, by the controller device 200 and compared to a user's currentblood glucose level.

In operation 1145, the controller device 200 can compare a recent bloodglucose level value to the modified upper and lower glucose alarm limitsfor the purpose of determining if the blood glucose value is outside ofa normal range. One exemplary comparison operation was previouslydescribed in connection with FIG. 17 (refer to operations 1025-1050). Itshould be understood that, while process 1000 (FIG. 17) depicts aprocess in which glucose alarm limits are modified and compared to auser's most recent blood glucose level, in other embodiments, thecontroller device 200 may compare the user's blood glucose level to boththe modified limits and the default glucose alarm limits. In suchembodiments, different alarms can be communicated to the user toindicate whether the user's blood glucose level falls outside of themodified range or the default range. For example, if the user's currentblood glucose level is below a default lower glucose limit, but above amodified lower limit, the user can be informed that the lower glucosealarm limit has been modified, but a low glucose alarm may not be given.

Referring now to FIG. 19, the upper and lower glucose alarm limitsassociated with a user and stored in the controller 200 can be modifiedin response to the user's TIL % value. As previously described inconnection with FIG. 13, the controller device 200 can estimate a user'sinsulin load by calculating the user's TIL % value from, for example, auser's TIL value and the user's theoretical basal TIL value. This TIL %value, along with additional information, such as the time the TIL %value was calculated, can be stored in the memory (e.g., the memory chip248) of the controller device 200 for use in, for example, modifying theuser's glucose alarm limits. For example, a process 1200 for modifyingthe upper and lower glucose alarm limits associated with a user, inresponse to the user's TIL % value, can be implemented by the controllerdevice 200. In operation 1205, the controller device 200 can retrieve auser's recent TIL % value from memory. In some embodiments, instead ofretrieving a recent TIL % value from memory, the controller device 200can initiate the calculation of a current TIL % value and utilize thisvalue in subsequent operations.

As previously described, the controller device 200 can include upper andlower glucose alarm limits (e.g., that define a normal blood glucoserange) that were previously stored in the memory of the controllerdevice 200. In operation 1210, the controller device 200 can retrieve anupper glucose alarm limit from memory.

In some circumstances (e.g., a user's insulin load is lower thannormal), the controller device 200 can provide enhanced user safety byreducing the high glucose alarm limit, which can alert the user to apotentially dangerous increase in blood glucose level sooner than if thehigh glucose alarm limit was not modified. In other circumstances (e.g.,a user's insulin load value is higher than normal), the controllerdevice 200 may reduce the likelihood of nuisance alarms by raising thehigh glucose alarm limit, which can provide additional convenience tothe user. For example, in operation 1215, the controller device 200 canuse the TIL % value obtained during operation 1205 and the upper glucosealarm limit obtained during operation 1210 to calculate a modified upperglucose alarm limit to increase the sensitivity of the high glucosealarm or decrease the likelihood and/or number of nuisance high glucosealarms. For example, the modified upper glucose alarm limit can becalculated as follows:Modified Upper Glucose Alarm Limit=Upper Glucose Alarm Limit×[1+(ScalingFactor_(Upper)×TIL %)]

-   -   where Scaling Factor_(Upper) represents a scaling factor, stored        in the controller device 200, that can be used to correlate        changes in the user's TIL % values to changes in the user's        upper glucose alarm limit and can include factors such as the        user's insulin sensitivity.

In operation 1220, the modified upper glucose alarm limit can be storedin the memory of the controller device 200, to be accessed later, forexample, by the controller device 200 and compared to a user's currentblood glucose level.

Still referring to FIG. 19, in some circumstances (e.g., a user'sinsulin load is higher than normal), the controller device 200 mayprovide enhanced user safety by increasing the low glucose alarm limit,which can alert the user to a potentially dangerous decrease in bloodglucose level sooner than if the low glucose alarm limit is notmodified. In other circumstances (e.g., a user's insulin load value islower than normal), the controller device 200 may reduce the likelihoodof nuisance alarms by lowering the low glucose alarm limit, which canprovide additional convenience to the user. In operation 1225, thecontroller device 200 can retrieve a lower glucose alarm limit frommemory. In operation 1230, the controller device 200 can use the TIL %value obtained during operation 1205 and the lower glucose alarm limitobtained during operation 1225 to calculate a modified lower glucosealarm limit to increase the sensitivity of the low glucose alarm ordecrease the number of nuisance low glucose alarms. For example, themodified upper glucose alarm limit can be calculated as follows:Modified Lower Glucose Alarm Limit=Lower Glucose Alarm Limit×[1+(ScalingFactor_(Lower)×TIL %)]

-   -   where Scaling Factor_(Lower) represents a scaling factor, stored        in the controller device 200, that can be used to correlate        changes in the user's TIL % values to changes in the user's        lower glucose alarm limit, and can include factors such as the        user's insulin sensitivity.

In operation 1235, the modified lower glucose alarm limit can be storedin the memory of the controller device 200, to be accessed later, forexample, by the controller device 200 and compared to a user's currentblood glucose level.

In operation 1240, the controller device 200 can compare a recent bloodglucose level value to the modified upper and lower glucose alarm limitsfor the purpose of determining if the blood glucose value is outside ofa normal range. An exemplary comparison was described in connection withFIG. 17 (refer to operations 1025-1050). As previously described, insome alternative embodiments other than the process shown in FIG. 17,the controller device 200 may compare the user's blood glucose level toboth the modified limits and the default glucose alarm limits. In theseembodiments, different alarms can be communicated to the user toindicate whether the user's blood glucose level falls outside of themodified range or the default range. For example, if the user's currentblood glucose level is above a default upper glucose limit, but below amodified upper limit, the user can be informed that the upper glucosealarm limit has been modified, but a high glucose alarm may not begiven.

In some embodiments, as described previously, a user can benefit fromincreasing the sensitivity of glucose alarms and/or decreasing thelikelihood of nuisance glucose alarms. The controller 200 can, inresponse to a user's insulin load (e.g., TIL values, TIL % value, IOB,or the like), increase the sensitivity of glucose alarms and/or decreasethe number of nuisance glucose alarms by modifying the upper and/orlower glucose alarm limits. A user's blood glucose level can then becompared to the modified glucose alarm limits to determine whether a lowor high glucose alarm should be communicated to the user. In someembodiments, for example as described in connection with FIGS. 18-19,the glucose alarm limits can be modified using equations thatincorporate TIL values, TIL % values, theoretical basal TIL values, orthe like. In some embodiments, the glucose alarm limits can be modifiedin response to a user's insulin load (e.g., TIL values, TIL % values, orthe like), but the insulin load values may not be used in the equationsemployed to calculate the modified the alarm limits.

Referring now to FIG. 20, in some embodiments, a user's insulin loadvalue can be compared to upper and/or lower insulin load thresholdvalues to determine if the insulin load value is outside a normal range.If the insulin load value is within a “Normal” range (e.g., between 1.5and 3.5 units in one particular example), the controller device 200 maynot modify the upper and lower glucose alarm limits, leaving the glucoserange as seen in default glucose alarm limit range 1300. If the insulinload value falls below the “Normal” range (e.g., into a “Low” range),the controller device 200 can increase the sensitivity of the upperglucose alarm limit and decrease the sensitivity of the lower glucosealarm limit by decreasing the value of each, as seen in low-loadmodified range 1310. If the insulin load value rises above the “Normal”range (e.g., into a “High” range, the controller device 200 can decreasethe sensitivity of the upper glucose alarm limit and increase thesensitivity of the lower glucose alarm limit by increasing the value ofeach, as seen in high-load modified range 1320.

In some embodiments, the upper and lower glucose alarm limits can bemodified by predetermined amounts based on the insulin load value. Forexample, if the insulin load value falls below the “Normal” range (e.g.,into the “Low” range), the controller device 200 can decrease the upperglucose alarm limit by 20 mg/dL (e.g., from 200 mg/dL to 180 mg/dL inthis example) and decrease the lower glucose alarm limit by 30 mg/dL(e.g., from 100 mg/dL to 70 mg/dL in this example). On the other hand.if the insulin load value rises above the “Normal” range (e.g., into the“High” range), the controller device 200 can increase the upper glucosealarm limit by 100 mg/dL (e.g., from 200 mg/dL to 300 mg/dL in thisexample) and increase the lower glucose alarm limit by 10 mg/dL (e.g.,from 100 mg/dL to 110 mg/dL in this example).

In alternative embodiments, the upper and lower glucose limits can bemodified by percentage amounts based on the insulin load value. Forexample, if the insulin load value falls below the “Normal” range (e.g.,into a “Low” range), the controller device 200 can decrease the upperglucose alarm limit by 15% (e.g., from 200 mg/dL to 170 mg/dL) anddecrease the lower glucose alarm limit by 40% (e.g., from 100 mg/dL to60 mg/dL). If the insulin load value rises above a “Normal” range (e.g.,into a “High” range), the controller device 200 can increase the upperglucose alarm limit by 40% (e.g., from 200 mg/dL to 280 mg/dL) andincrease the lower glucose alarm limit by 15% (e.g., from 100 mg/dL to115 mg/dL).

As previously described, such modifications to the alarms limits can bebased at least in part of the user's insulin load. Thus, in someembodiments, the glucose alarm limits can be modified (e.g., by fixedamounts, percentages, or the like) in response to the user's TIL valueor TIL % value rising above or falling below a normal range. In stillother embodiments, a user's glucose alarm limits can be modified inresponse to the user's insulin load (e.g., TIL value, TIL % value,insulin-on-board estimations, or the like) being outside of a normalrange using equations, such as those described in connection with FIGS.18-19, to modify the upper and lower glucose alarm limits.

Referring now to FIG. 21, the controller device 200 can be used tomodify a user's upper and lower glucose alarm limits in response to acomparison between a user's insulin load (e.g., TIL value, TIL % value,IOB, or the like) and a predetermined range. For example, a process 1400for modifying a user's upper and lower glucose alarm limits in responseto a comparison between the user's current TIL value and upper and lowerTIL threshold values can be implemented by the controller device 200. Aspreviously described, the controller device 200 can determine a user'sTIL values and store these values in memory. In operation 1405, thecontroller device 200 can retrieve a user's recent TIL value from memory(e.g., the memory chip 248). In some embodiments, the controller device200 can retrieve the TIL value by initiating a new calculation for acurrent TIL value. In operation 1410 the controller device 200 canretrieve, from memory, an upper TIL threshold.

In operation 1415, the controller device 200 can compare the TIL valueretrieved in operation 1405 to the upper threshold retrieved inoperation 1410. If the TIL value is greater than the upper TIL thresholdvalue, the process 1400 continues to operation 1420 where the controllerdevice 200 can retrieve an upper glucose alarm limit from memory. Inoperation 1425, the controller device 200 can calculate a modified upperglucose alarm limit that can be used to, for example, decrease thesensitivity of the high glucose alarm. In this example, the modifiedupper glucose alarm limit can be calculated as follows:Modified Upper Glucose Alarm Limit=Upper Glucose Alarm Limit×HighScaling Factor_(Upper)

-   -   where High Scaling Factor_(Upper) represents a scaling factor        (e.g., stored in the controller device 200) that can be used to        modify the user's upper glucose alarm limit in response to high        TIL values.

In operation 1430, the controller device 200 can retrieve a lowerglucose alarm limit from memory. In operation 1435, the controllerdevice 200 can calculate a modified lower glucose alarm limit that canbe used to, for example, increase the sensitivity of the low glucosealarm. The modified lower glucose alarm limit can be calculated asfollows:Modified lower Glucose Alarm Limit=Lower Glucose Alarm Limit×HighScaling Factor_(Lower)

-   -   where High Scaling Factor_(Lower) represents a scaling factor        (e.g., stored in the controller device 200) that can be used to        modify the user's lower glucose alarm limit in response to high        TIL values.

After completing operation 1435, the process 1400 can execute operation1440 where the controller device 200 can standby for a new TIL value tobecome available before returning to operation 1400.

It should be understood that, after the modified upper and lower glucosealarm limits are calculated, the new alarm limit values can be stored inmemory of the controller device 200. As such, the controller device 200can compare a recent blood glucose level value to the modified upper andlower glucose alarm limits for the purpose of determining if the bloodglucose value is outside of a normal range. One exemplary comparisonoperation was previously described in connection with FIG. 17 (refer tooperations 1025-1050).

Revisiting now the comparison made during operation 1415, if thecontroller device 200 determines that the TIL value retrieved duringoperation 1405 is not greater than the upper TIL threshold value, theprocess 1400 can execute operation 1445 and the controller device 200can retrieve, from memory, a lower TIL threshold. In operation 1445, thecontroller device 200 can compare the TIL value retrieved in operation1405 to the lower threshold value from memory. If the TIL value is lessthan the lower TIL threshold value, the process 1400 can executeoperation 1455 where the controller device 200 can retrieve an upperglucose alarm limit from memory. In operation 1460, the controllerdevice 200 can calculate a modified upper glucose alarm limit that canbe used to, for example, increase the sensitivity of the high glucosealarm. In this example, the modified upper glucose alarm limit can becalculated as follows:Modified Upper Glucose Alarm Limit=Upper Glucose Alarm Limit×Low ScalingFactor_(Upper)

-   -   where Low Scaling Factor_(Upper) represents a scaling factor        (e.g., stored in the controller device 200) that can be used to        modify the user's upper glucose alarm limit in response to low        TIL values.

In operation 1465, the controller device 200 can retrieve a lowerglucose alarm limit from memory. In operation 1470, the controllerdevice 200 can calculate a modified lower glucose alarm limit that canbe used to, for example, decrease the sensitivity of the low glucosealarm. In this example, the modified lower glucose alarm limit can becalculated as follows:Modified lower Glucose Alarm Limit=Lower Glucose Alarm Limit×Low ScalingFactor_(Lower)

-   -   where Low Scaling Factor_(Lower) represents a scaling factor        (e.g., stored in the controller device 200) that can be used to        modify the user's lower glucose alarm limit in response to low        TIL values.

After completing operation 1470, the process 1400 can continue on tooperation 1440 where the controller device 200 can standby for a new TILvalue to become available before returning to operation 1400.

As previously described, after the modified upper and lower glucosealarm limits are calculated, the new alarm limit values can be stored inmemory of the controller device 200. As such, the controller device 200can compare a recent blood glucose level value to the modified upper andlower glucose alarm limits for the purpose of determining if the bloodglucose value is outside of a normal range. One exemplary comparisonoperation was previously described in connection with FIG. 17 (refer tooperations 1025-1050).

Revisiting now the comparison made during operation 1445, if thecontroller device 200 determines that the TIL value retrieved duringoperation 1405 is not less than the lower TIL threshold value, theprocess 1400 can execute operation 1440 where the controller device 200can standby for a new TIL value to become available before returning tooperation 1400. In the previously described embodiment, three insulinload ranges (e.g., “Normal”, “High”, and “Low”) were used to determinedhow the glucose alarm limits were to be modified. In other embodiments,a different number of insulin load ranges (e.g., 4, 2, 5, or the like)can be used, each defining a different way to modify the glucose alarmlimits. In some embodiments, other insulin load values (e.g., TIL %,IOB, or the like) can be used to determine if a user's blood glucosealarm limits are to be modified. In some embodiments, the upper andlower glucose alarm limits can be modified, when the user's insulin loadis outside of a normal range, by equations similar to the equationsdescribed in connection with FIGS. 18-19.

Referring now to FIGS. 22-25, some embodiments of the controller device200 can be used to provide alarms other than “high” or “low” bloodglucose levels. For example, when receiving data indicative of a user'sblood glucose levels e.g., data from the monitoring device 50, bloodglucose levels input into the user interface 220, data from a glucosetest strip reader built into the controller device 200, or the like, thecontroller device 200 can be configured to provide one or more of a“missed bolus” alarm and a “missed meal” alarm. The controller device200 can identify, from stored blood glucose values, one or moreconditions that indicate a user experienced a missed bolus situation ora missed meal situation. Identifying a missed meal and/or missed bolussituation can benefit the user in that this information can be used bythe controller device 200 to prompt corrective action (e.g., promptingthe user to consume carbohydrates, prompting the user for input in orderto suggest a bolus dosage, prompting the user to input data related to ameal previously consumed, or the like) before the user's blood glucoselevel has risen or fallen out of a normal range. In some embodiments,the “missed meal” alarm and/or the “missed bolus” alarm can be suspendedduring particular periods of the day (e.g., when the user is sleeping)to minimize or eliminate the occurrence of nuisance alarms.

Referring now to FIG. 22, in some embodiments, the controller device 200can utilize stored data indicative of a user's blood glucose level(e.g., detected by the monitoring device 50) to identify a missed bolussituation that can occur, for example, when the user consumes a mealcontaining carbohydrates, but does receive a bolus to offset thecarbohydrate intake. A missed bolus situation can occur when a userforgets to enter a meal into the controller device 200, does not accepta suggested bolus dosage, cancels a bolus dosage, or the like. As partof the normal operation of the infusion pump system 10, the controllerdevice 200 can periodically (e.g., every one minute, every two minutes,every five minutes, every fifteen minutes, every hour, every two hours)or selectively (e.g., when prompted by the user or the like) receivedata indicative of a user's blood glucose level. For example, thecontroller device 200 may receive detected glucose information from themonitoring device 50 every one minute, every two minutes, every fiveminutes, every fifteen minutes, or the like. Such data can be stored ina memory device of the controller device 200. In these circumstances,the controller device 200 can retrieve previously stored data indicativeof a user's blood glucose level for a period of time (e.g., a recent15-minute period, a recent 30-minute period, a recent 1-hour period, arecent 3-hour period, or the like) and can evaluate this data forinformation indicative of a missed bolus situation.

In FIG. 22, graph 1500 provides an example of a blood glucose curve 1510generated from the blood glucose data that was stored in the memory ofthe controller device 200. In some embodiments, the controller device200 can be configured to recognize one or more patterns, within the datadepicted by the glucose curve 1510, indicative of a missed bolussituation. For example, the controller device 200 can identify apotential missed bolus situation by recognizing a local minimum withinthe glucose curve 1510, such as the local minimum that occurs proximateto data point 1512. Exemplary methods used by the controller device 200to recognize a local minimum can include determining the local minimumby evaluating the curve 1510 graphically and/or determining the localminimum mathematically. In some embodiments, the controller device 200can identify a local minimum by identifying data points on the curve(e.g., the data point 1512) where the closest data point to the left(such as the data point 1513) and the closest data point to the right(e.g., the data point 1514) are greater than the data point itself. Insome embodiments, the controller device 200 can estimate the first andsecond derivatives of the glucose curve 1510 and can test the first andsecond derivatives for conditions that indicate a local minimum. Forexample, if the controller device 200 locates a point in the curve 1510where the first derivative is equal to zero and the second derivative ispositive, the located point may be a local minimum and can potentiallyindicate that the user is experiencing a missed bolus situation.

Still referring to FIG. 22, the controller device 200 can be configuredto perform other operations to determine if the user is experiencing amissed bolus situation. In some embodiments, the controller device 200may evaluate more than two neighboring points (e.g., more than one oneach side) of a test point when determining a missed bolus situation.The controller device 200 can evaluate the blood glucose data for aperiod of time before and a period of time after a potential localminimum to determine if the user is experiencing a missed bolussituation. For example, the controller device 200 can evaluate a onehour period of time (e.g., one-half hour before the point 1512 andone-half hour after the point 1512) to determine if the data depicted bythe glucose curve 1510 indicates a missed meal situation. The controllerdevice 200 can evaluate all the points, within a period of time (e.g.,one-half hour), to the left of a local minimum and all of the points,within a period of time (e.g., one-half hour), to the right of the localminimum. If each of the evaluated points prior to the local minimum hasa lesser value than the previous point (moving from lowest time tohighest time), and if each of the evaluated points to the right of thelocal minimum has a greater value than the previous point (moving fromlowest time to highest time), then the controller device 200 candetermine that the local minimum indicates that the user is experiencinga missed bolus situation. For example, if the order of data points 1512,1513, and 1515, from highest to lowest value, is point 1515, point 1513,and point 1512 and the order of points 1512, 1514, and 1516, from lowestto highest value, is point 1512, point 1514, and point 1516, then thecontroller device 200 can identify a missed bolus situation. It shouldbe understood, that in particular alternative embodiments, thecontroller device 200 can be configured to identify a possible missedbolus situation where the blood glucose data points reveal a change inslope (e.g., from a steep downward slope toward a flatter slope) ratherthan a complete reversal of slope at a local minimum.

When examining the user's blood glucose data (refer to blood glucosecurve 1510) prior to point 1512, the user's blood glucose level is notonly within a normal range (e.g., 100 mg/dL to 200 mg/dL), but thevalues are falling. If only considering the blood glucose level (referto curve 1510), the controller device 200 may not identify the existenceof a situation that needs to be corrected until point 1517 where theuser's blood glucose level rises above the user's normal blood glucoserange (e.g., 100 mg/dL to 200 mg/dL in this embodiment). In the exampledepicted here, the user's blood glucose level remains within the normalrange until reaching point 1517 (at about time=11.5 hours). After thepoint 1517, the controller device 200 can alert the user of a high bloodglucose level and can prompt the user to take corrective action (e.g.,receive a bolus dosage of insulin). However, the controller device 200can monitor the user's blood glucose data for the purpose of identifying“missed bolus” situations before the user's blood glucose levelincreases beyond the upper alarm limit. In the embodiment describedhere, the controller device 200 can identify the presence of a missedbolus situation prior to point 1517 (e.g., at point 1514, at point 1516,or the like)—about 2 to about 2.5 hours prior to point 1517 when theuser's blood glucose level increases beyond the upper alarm limit. Inthis example, the controller device 200 can alert the user of thepotential missed bolus situation at about time=9.25 hours and prompt theuser to take corrective action, possibly avoiding the potentially unsafeincrease in blood glucose level.

Still referring to the embodiment depicted by FIG. 22, when thecontroller device identifies a missed bolus situation, the controllerdevice 200 can prompt the user to enter a previously consumed meal. Forexample, the missed bolus situation could have been caused by the userforgetting to enter a previously consumed meal that includedcarbohydrates and the prompt, by the controller device 200, can remindthe user to enter this information. Thereafter, the controller device200 can suggest a bolus insulin dosage to offset the consumedcarbohydrates. If the user does not enter meal information, thecontroller device 200 can prompt the user to receive a bolus dosagebased on, for example, the slope of the blood glucose curve 1510 at thelatest point where a slope can be calculated (e.g., at point 1514). Inthe example depicted in FIG. 22, the controller device 200 can promptthe user to take corrective action about 1.5 to 2 hours earlier, if thecontroller device 200 monitors the blood glucose data for patternsindicative of a missed bolus situation, than if the controller device200 monitors only the blood glucose level (refer to curve 1510). Such afeature can provide enhanced protection for the user, who would have theopportunity to select a corrective bolus before the blood glucose levelincreased above the normal range, potentially maintaining the user'sblood glucose in a normal range when it would otherwise rise to anunsafe level.

Referring now to FIG. 23, the controller device 200 can be used toidentify a missed bolus situation that can be indicative of, forexample, the user consuming a meal and not receiving a bolus dosage ofinsulin to offset the meal carbohydrates. In some embodiments, a process1550 for identifying a missed bolus situation using blood glucoseinformation can be implemented by the controller device 200. Aspreviously described, the controller device 200 can receive and storeinformation indicative of a user's blood glucose level. In operation1555, the controller device 200 can receive data indicative of theuser's blood glucose level for a period of time from the monitoringdevice 50. In operation 1565, the controller device 200 can evaluate theblood glucose data for information that is indicative of a missed bolussituation. For example, the controller device 200 can be configured toanalyze the data points from (e.g., a recent 15-minute period, a recent30-minute period, a recent 1-hour period, a recent 3-hour period, or thelike). During the analysis, the controller device 200 can locate localminima as described previously in connection with FIG. 22. In anotherexample, the controller device 200 can identify local minima and applyadditional tests, such as those described in connection with FIG. 22, todetermine if data indicative of a missed bolus situation is present. Inan alternative example, the controller device 200 can identify apossible missed bolus situation where the blood glucose data pointsreveal a change in slope (e.g., from a steep downward slope toward aflatter slope) rather than a complete reversal of slope at a localminimum. If, in operation 1570, the controller device 200 does notidentify information indicative of a missed bolus situation, the process1550 can return to operation 1555 where the controller device 200 canstandby to receive additional blood glucose data.

If the controller device 200, in operation 1570, does identifyinformation indicative of a missed bolus situation, the process 1550 canexecute process 1575 in which the controller device 200 can check if theuser has recently received a bolus dosage. For example, if the userreceived a bolus delivery fifteen minutes prior to the identification ofthe missed bolus situation, the insulin received during that bolusdosage may not have significantly acted yet on the user. In thisexample, the controller device 200 may have identified a missed bolussituation because the insulin delivered did not yet have time to takeeffect. In this example, no alert is communicated to the user and theprocess 1550 can return to operation 1555 where the controller device200 can standby to receive additional blood glucose data.

If, in operation 1575, the controller device 200 determines that theuser has not recently received a bolus dosage of insulin, the process1550 can execute operation 1580 and the controller device 200 can outputa “missed bolus” alarm to the user. At this time, the user can beoptionally prompted to enter data indicative of a previously consumedmeal that was not previously entered into the controller device 200. Inoperation 1585, the controller device 200 can prompt the user for inputto a bolus calculation. For example, after the “missed bolus” alarm iscommunicated, the user interface 220 of the controller device 200 canenter a bolus suggestion menu in which the user is prompted to enterdata so that a suitable bolus dosage can be calculated. The suggestedbolus dosage can be displayed to the user, and the user can be promptedto begin delivery of the bolus dosage (to thereby correct the previouslymissed bolus situation before the user's blood glucose level reaches theupper alarm limit conditions).

Referring now to FIG. 24, in some embodiments, the controller device 200can utilize stored data indicative of a user's blood glucose level(e.g., detected by the monitoring device 50) to identify a “missed meal”situation. For example, the missed meal situation may arise when theuser receives a bolus dosage of insulin in response to a planned meal,but then fails to consume that particular meal. As part of the normaloperation of the infusion pump system 10, the controller device 200 canperiodically (e.g., every one minute, every two minutes, every fiveminutes, every fifteen minutes, every hour, every two hours) orselectively (e.g., when prompted by the user or the like) receive dataindicative of a user's blood glucose level. For example, the controllerdevice 200 may receive detected glucose information from the monitoringdevice 50 every one minute, every two minutes, every five minutes, everyfifteen minutes, or the like. Such data can be stored in a memory deviceof the controller device 200. In these circumstances, the controllerdevice 200 can retrieve previously stored data indicative of a user'sblood glucose level for a period of time (e.g., a recent 15-minuteperiod, a recent 30-minute period, a recent 1-hour period, a recent3-hour period, or the like) and can evaluate this data for the presenceof information indicative of a “missed meal” situation. In certainembodiments, the controller device 200 may initiate the inquiry into the“missed meal” situation only after the delivery of a meal bolus ofinsulin (e.g., within a 1-hour period after the delivery of a mealbolus).

In FIG. 24, graph 1600 provides an example of a blood glucose curve 1610generated from the blood glucose data that was stored in the memory ofthe controller device 200. In some embodiments, the controller device200 can be configured to recognize one or more patterns, within the datadepicted by the glucose curve 1610, indicative of a missed mealsituation. For example, the controller device 200 can identify apotential missed meal situation by recognizing a local maximum withinthe glucose curve 1610, such as the local maximum that occurs proximateto data point 1612. Exemplary methods used by the controller device 200to recognize a local maximum can include determining the local maximumby evaluating the curve 1610 graphically and/or determining the localmaximum mathematically. In some embodiments, the controller device 200can identify a local maximum by identifying data points on the curve(e.g., the data point 1612) where the closest data point to the left(such as the data point 1613) and the closest data point to the right(e.g., the data point 1614) are less than the data point itself. In someembodiments, the controller device 200 can estimate the first and secondderivatives of the glucose curve 1610 and can test the first and secondderivatives for conditions that indicate a local maximum. For example,if the controller device 200 locates a point in the curve 1610 where thefirst derivative is equal to zero and the second derivative is negative,the located point may be a local maximum and can potentially indicatethat the user is experiencing a missed meal situation.

Still referring to FIG. 24, the controller device 200 can be configuredto perform other operations to determine if the user is experiencing amissed meal situation. In some embodiments, the controller device 200may evaluate more than two neighboring points (e.g., more than one oneach side) of a test point when determining a missed meal situation. Thecontroller device 200 can evaluate the blood glucose data for a periodof time before and a period of time after a potential local maximum todetermine if the user is experiencing a missed meal situation. Forexample, the controller device 200 can evaluate a one hour period oftime (e.g., one-half hour before the point 1612 and one-half hour afterthe point 1612) to determine if the data depicted by the glucose curve1610 indicates a missed meal situation. The controller device 200 canevaluate all the points, within a period of time (e.g., one-half hour),to the left of a local maximum and all of the points, within a period oftime (e.g., one-half hour), to the right of the local maximum. If eachof the evaluated points prior to the local maximum has a greater valuethan the previous point (moving from lowest time to highest time), andif each of the evaluated points to the right of the local maximum has alesser value than the previous point (moving from lowest time to highesttime), then the controller device 200 can determine that the localmaximum indicates that the user is experiencing a missed meal situation.For example, if the order of data points 1612, 1613, and 1615, fromlowest to highest value, is point 1615, point 1613, and point 1612 andthe order of points 1612, 1614, and 1616, from highest to lowest value,is point 1612, point 1614, and point 1616, then the controller device200 can identify a missed meal situation. It should be understood, thatin particular alternative embodiments, the controller device 200 can beconfigured to identify a possible missed meal situation where the bloodglucose data points reveal a change in slope (e.g., from a steep upwardslope toward a flatter slope) rather than a complete reversal of slopeat a local maximum.

When examining the user's blood glucose data (refer to blood glucosecurve 1610) prior to point 1612, the user's blood glucose level is notonly within a normal range (e.g., 100 mg/dL to 200 mg/dL), but thevalues are rising. If only considering the blood glucose level (refer tocurve 1610), the controller device 200 may not identify the existence ofa situation that needs to be corrected until point 1617 where the user'sblood glucose level falls below the user's normal blood glucose range(e.g., 100 mg/dL to 200 mg/dL in this embodiment). In the exampledepicted here, the user's blood glucose level remains within the normalrange until reaching point 1617 (at about time=10.25 hours). After thepoint 1617, the controller device 200 can alert the user of a low bloodglucose level and can prompt the user to take corrective action (e.g.,consume a meal of carbohydrates). However, the controller device 200 canmonitor the user's blood glucose data for the purpose of identifying“missed meal” situations before the user's blood glucose level decreasesbelow the lower alarm limit. In the embodiment described here, thecontroller device 200 can identify the presence of a missed mealsituation prior to point 1617 (e.g., at point 1614, at point 1616, orthe like)—about 1 to about 1.5 hours prior to point 1617 when the user'sblood glucose level decreases below the lower alarm limit. In thisexample, the controller device 200 can alert the user of the potentialmissed meal situation at about time=9 hours and prompt the user to takecorrective action, possibly avoiding the potentially unsafe decrease inblood glucose level.

Still referring to the embodiment depicted by FIG. 24, when thecontroller device identifies a missed meal situation, the controllerdevice 200 can prompt the user to consume a previously entered meal. Forexample, the missed meal situation could have been caused by the userneglecting to consume a meal that was previously entered into thecontroller device 200. When alerted by the controller device 200, theuser can be reminded to consume this previously entered meal. If theuser has consumed all meals that were previously entered into thecontroller device 200, the controller device 200 can prompt the user toconsume a carbohydrate including meal that is based on, for example, theslope of the blood glucose curve 1610 at the latest point where a slopecan be calculated (e.g., at point 1614). In the example depicted in FIG.24, the controller device 200 can prompt the user to take correctiveaction about 1 to 1.5 hours earlier, if the controller device 200monitors the blood glucose data for patterns indicative of a missed mealsituation, than if the controller device 200 monitors only the bloodglucose level (refer to curve 1610). Such a feature can provide enhancedprotection for the user, who would have the opportunity to consume ameal before the blood glucose level decreased below the normal range,potentially maintaining the user's blood glucose in a normal range whenit would otherwise fall to an unsafe level.

Referring now to FIG. 25, the controller device 200 can be used toidentify a missed meal situation that can be indicative of, for example,the user receiving a bolus dosage of insulin to offset an entered mealof carbohydrates, but not consuming the entered meal. In someembodiments, a process 1650 for identifying a missed meal situationusing blood glucose information can be implemented by the controllerdevice 200. As previously described, the controller device 200 canreceive and store information indicative of a user's blood glucoselevel. In operation 1655, the controller device 200 can receive dataindicative of the user's blood glucose level for a period of time (e.g.,one hour, two hours, three and a half hours, or the like) from memory(e.g., the memory chip 248). In operation 1660, the controller device200 can evaluate the blood glucose data for the presence of informationthat is indicative of a missed meal situation. For example, thecontroller device 200 can locate local maxima as described previously inconnection with FIG. 24. In another example, the controller device 200can identify local maxima and apply additional tests, such as thosedescribed in connection with FIG. 24 (e.g., testing multiple pointsaround a local maximum), to determine if data indicative of a missedmeal situation is present. If, in operation 1665, the controller device200 does not identify information indicative of a missed meal situation,the process 1650 can return to operation 1655 where the controllerdevice 200 can standby to receive additional blood glucose data.

If the controller device 200, in operation 1665, does identifyinformation indicative of a missed meal situation, the process 1650 canoptionally execute process 1670 in which the controller device 200 cancheck if the user has recently (e.g., within the last 30 minutes, withinthe last 2 hours, within the last four hours, or the like) received abolus dosage (e.g., a bolus dosage, intended to offset an entered meal).For example, a missed meal situation can be defined as a situation inwhich the user enters information about a consumed meal into thecontroller device 200, but neglects to consume the meal. In thisexample, the controller device 200 may not define a situation (e.g.,sudden drop in blood glucose level) as a missed meal situation if acarbohydrate-offsetting bolus of insulin was not recently received bythe user. In other examples, a missed meal situation can be identifiedeven if a carbohydrate-offsetting bolus has not been received recentlyby the user. If, in optional operation 1670, the controller device 200determines that the user has not recently received a bolus dosage, theprocess 1650 can return to operation 1655 where the controller device200 can standby to receive additional blood glucose data.

If, in operation 1670, the controller device 200 determines that theuser has recently received a bolus dosage of insulin, the process 1650can execute operation 1675 and the controller device 200 can output a“missed meal” alarm to the user. In operation 1685, the controllerdevice 200 can prompt the user to enter whether or not the userpreviously entered a meal, but neglected to consume it. For example, ifthe user did previously enter a meal and neglected to consume it, theuser can indicate this to the controller device 200 and thus be promptedto consume the meal. However, if the user indicates that he/she hasconsumed all previously entered meals, this could be indicative of someother problem (e.g., an incorrectly entered meal), and the controllerdevice 200 can optionally take additional action, such as suggesting anadditional meal. In operation 1680, if the controller device 200determines that the user did neglect to consume a previously enteredmeal, the controller device 200 can execute operation 1685, promptingthe user to consume the recently entered meal, thereby correcting themissed meal situation before the user's blood glucose level falls belowthe lower alarm limit conditions. If, however, the controller devicedetermines, in operation 1680, that the user has consumed all previouslyentered meals, the controller device 200 can optionally executeoperation 1690, prompting the user with a suggested meal to be consumed.The suggested meal can be based on, as described in greater detail inconnection with FIG. 24, the slope of a graph of the user's recent bloodglucose information. Consuming a meal based on a “missed meal” alarm cancorrect, or prevent, a potentially unsafe drop in blood glucose levelearlier than a correction based only on blood glucose level.

A number of embodiments of the invention have been described.Nevertheless, it will be understood that various modifications may bemade without departing from the spirit and scope of the invention.Accordingly, other embodiments are within the scope of the followingclaims.

What is claimed is:
 1. A medical infusion pump system, comprising: aportable pump housing that receives insulin for dispensation to a user,the pump housing at least partially containing a pump drive system todispense the insulin through a flow path to the user; and a controllerthat communicates with the pump drive system to dispense the insulinfrom the portable pump housing, the controller being configured tocalculate an insulin load of the user representing an estimated amountof insulin delivered to the user's body which has not yet acted, whereinthe controller receives glucose information indicative of a detectedblood glucose level of the user, and wherein the controller outputs analarm when the glucose information indicates that the detected bloodglucose level reaches beyond a glucose alarm limit parameter, theglucose alarm limit parameter being adjustable by the controller inresponse to the insulin load of the user representing the estimatedamount of insulin delivered to the user's body which has not yet acted.2. The system of claim 1, wherein the insulin load of the user iscalculated as a total insulin load indicative of bolus and basal insulindosages that have dispensed but not yet acted in the user.
 3. The systemof claim 2, wherein the total insulin load is determined by thecontroller according to a function that accounts for (i) a bolus insulinload indicative of one or more bolus insulin dosages that have beendispensed into the user but not yet acted in the user, (ii) a basalinsulin load indicative of one or more basal insulin dosages that havebeen dispensed into the user from the portable infusion pump system butnot yet acted in the user; and (iii) a previous food component basedupon previous food intake that has not yet metabolized in the user. 4.The system of claim 1, further comprising a monitoring device thatcommunicates the glucose information to the controller, and acomputer-readable memory device coupled to the controller that storesthe glucose information received from the monitoring device and timevalues associated with the glucose information.
 5. The system of claim4, wherein the monitoring device comprises a portable housing wearableon the user's skin, a sensor shaft that penetrates into the user's skin,and a wireless communication device to transmit the glucose informationto a wireless communication device of the controller.
 6. The system ofclaim 1, wherein the controller outputs the alarm when the glucoseinformation indicates that the blood glucose level increases above anupper glucose alarm limit parameter or decreases below a lower glucosealarm limit parameter.
 7. The system of claim 1, wherein the controllerincreases the glucose alarm limit parameter when the user's insulin loadis calculated to be greater than a predetermined insulin load range. 8.The system of claim 7, wherein the controller decreases the glucosealarm limit parameter when the user's insulin load is calculated to belower than a predetermined insulin load range.
 9. The system of claim 1,further comprising a user interface coupled to the controller, the userinterface including a display device that indicates when the glucosealarm limit parameter is adjusted by the controller in response to theinsulin load of the user.
 10. The system of claim 9, wherein the displaydevice contemporaneously displays a glucose value indicative of theblood glucose level of the user and a calculated insulin load valueindicative of estimated amount of insulin delivered to the user's bodywhich has not yet acted.
 11. The system of claim 1, wherein the glucosealarm limit parameter is dynamically changed over time by the controlleras the insulin load of the user increases or decreases.
 12. The systemof claim 1, wherein the insulin load of the user represents a sum ofbolus dosages delivered to the user within a predetermined period oftime.
 13. A method of operating an insulin infusion pump system,comprising: receiving glucose information indicative of a detected bloodglucose level of a user; determining an insulin load of the userindicative of an estimated amount of insulin delivered to the user'sbody which has not yet acted; in response to the determination of saidinsulin load of the user indicative of said estimated amount of insulindelivered to the user's body which has not yet acted, modifying at leastone of an upper alarm limit parameter and a lower alarm limit parameter;and outputting an alarm when the glucose information indicates that thedetected blood glucose level is greater than the modified upper alarmlimit parameter or is less than the modified lower alarm limitparameter.
 14. The method of claim 13, further comprising activating apump drive system to dispense the insulin through a flow path to theuser.
 15. The method of claim 13, wherein receiving the glucoseinformation comprises receiving a signal from a wireless glucosemonitoring device wearable on the user's body.